News

• Clinical Advisory Board will provide guidance as Allay advances ATX101 through registrational trials in total knee arthroplasty (TKA) and future indications
• Scientific Advisory Board will advise on CMC and non-clinical development as well as new pipeline opportunities that build upon Allay’s novel drug delivery platform

SAN JOSE, CA, October 24, 2024 (BUSINESSWIRE) –  Allay Therapeutics, a clinical-stage biotechnology company pioneering ultra-sustained analgesic products to transform post-surgical pain management and recuperation, today announced the expansion of its Clinical and Scientific Advisory Boards to support the company as it advances its clinical candidate ATX101 and develops its pipeline to support patients, physicians and payors with novel, extended-duration post-surgical pain management solutions.

With the expansion of these advisory boards, Allay has appointed nine preeminent, internationally recognized subject matter experts across pain management, orthopedics, clinical research, drug delivery, pharmacology and anesthesiology to provide strategic guidance around major company initiatives, including the Phase 2B registration trial of Allay‘s lead investigational product, ATX101.

Allay’s expanded Clinical Advisory Board (CAB) now includes the following members:

• Sabry Ayad, M.D., M.B.A.
• Ron Burch, M.D., Ph.D.
• David Dalury, M.D.
• Hemant Pandit, FRCS, D.Phil
• Christine Sang, M.D., M.P.H.

Allay’s expanded Scientific Advisory Board (SAB) now includes the following members:

• Christine Allen, Ph.D.
• Ron Burch, M.D., Ph.D.
• Joachim Kohn, Ph.D.
• Louis L. Radulovic, Ph.D., M.P.H.
• Arthur Tipton, Ph.D.

“As we advance further into our late-stage registration trials and progress our ultra-sustained pipeline, we are pleased to have attracted a talented team of distinguished physicians and scientists to our expanded Clinical and Scientific Advisory Boards.  We look forward to the significant insights and expertise these thought leaders will bring to Allay based on their diverse experiences in drug delivery and elution, pharmacology, surgical specialties, pain management, and anesthesiology,” said Adam Gridley, Chief Executive Officer at Allay Therapeutics. “The collective knowledge and insights of these appointees will provide welcome guidance as we navigate the complexities of the global clinical trial and regulatory landscapes, work to bring ATX101’s potential to patients in need, and build on our platform technology to develop novel extended-duration solutions to transform pain management for patients, physicians, payors and healthcare systems worldwide.”

Clinical and Scientific Advisory Board Biographies:

Sabry Ayad, M.D. – Clinical Advisory Board

Sabry Ayad, M.D., is a Professor of Anesthesiology at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, a fellow of the American Society of Anesthesiologists, and the President of the Cleveland Society of Anesthesiologists. In addition, Dr. Ayad is also a senior member of multiple medical societies and committees, such as the American Society of Anesthesiologists (ASA), the American Society of Regional Anesthesia and Pain Medicine (ASRA), Society of Ambulatory Anesthesia (SAMBA), Society of Cardiovascular anesthesiologists (SCA), the Ohio Society of Anesthesiologists (OSA) and the International Anesthesia Research Society (IARS). He has published multiple peer-reviewed manuscripts focused on enhanced recovery after surgery (ERAS), AI and perioperative outcomes, and investigating topics related to postoperative nausea and vomiting, pain management, fluid and hemodynamic management, and anesthetic pharmacology. In 2016, Dr. Ayad was named Fairview Hospital Cleveland Clinic’s Physician of the Year and Safety Champion by the Cleveland Clinic Quality Institute. He earned his M.D. from Alexandria University, M.B.A. from Cleveland State University. 

Ron Burch, M.D., Ph.D. – Clinical Advisory Board + Scientific Advisory Board

Ron Burch, M.D., Ph.D., currently serves as Chief Medical Officer of Gate Neurosciences, a company developing products to treat psychiatric disorders. He previously served as Chief Medical Officer at Naurex, a clinical-stage biopharmaceutical company developing novel NMDA receptor modulators, and Pacira, an industry leader in non-opioid solutions for pain. Dr. Burch has served as Chairman of Zeneca Pharmaceuticals’ Global CNS Therapeutics Area Team; co-founder and CEO of AlgoRx Pharmaceuticals, a company that successfully developed a number of therapeutic agents for pain management; CEO of Sanguistat, a medical device company that developed devices that inhibited hemorrhage following serious wounds, CEO and Chairman of Biowave Corporation, a medical device company that successfully launched three neurostimulation products to treat chronic, intractable pain and postoperative pain; and Scientific Advisor of Collegium Pharmaceuticals. He also held various managerial positions with Purdue Pharma, including Vice President of Scientific Evaluations and Immunotherapeutics, Medical Director and Project Manager and Medical Safety Officer for several pain development programs. Dr. Burch was a researcher at the National Institutes of Health, performing research involving neuroreceptor regulation with Nobel Laureate Dr. Julius Axelrod. Dr. Burch obtained a Ph.D. in Pharmacology and M.D. from the Medical University of South Carolina. He holds bachelor’s degrees in chemistry and marine biology from the College of Charleston.

David Dalury, M.D. – Clinical Advisory Board

David Dalury, M.D., is an Orthopedic Surgeon specializing in total knee replacement, partial knee replacement and total hip replacement. He is a Clinical Professor of Orthopedic Surgery (Emeritus) at the University of Maryland Medicine and has been Chief of Orthopedics at the University of Maryland St. Joseph Medical Center. He is an active member of The Knee Society, the American Association of Orthopedic Surgeons and the American Association of Hip and Knee Surgeons, among other medical associations. His work has been published extensively in peer-reviewed publications. Dr. Dalury is a graduate of Dartmouth Medical School, and he completed his residency and Fellowship in Total Joint Replacement at the Harvard-affiliated hospitals.

Hemant Pandit, FRCS, D.Phil – Clinical Advisory Board

Hemant Pandit, FRCS (Orth), D.Phil (Oxon) is a Professor of Orthopaedic Surgery at University of Leeds and at University of Oxford, UK, and currently practices at Chapel Allerton Hospital, C/O Leeds Teaching Hospitals NHS Trust in the UK. Hemant has a high-volume hip and knee arthroplasty practice and is also a clinical academic. In addition, he holds the post of Deputy Dean in the Faculty of Medicine and Health C/O University of Leeds and is Head of School (Leeds Institute of Rheumatic Musculoskeletal Medicine). Dr. Pandit has published 400+ peer-reviewed articles, written 50+ book chapters and leads a multi-disciplinary team of 20+ colleagues. His research interest is focused on translational research across the entire osteoarthritis spectrum aimed at improving patient outcomes and optimizing their management pathways. Hemant’s work on pain relief post knee arthroplasty is well recognized. Hemant is a NIHR Senior Investigator, an elected member of the American Knee Society and European Knee Society and is an MHRA (Medicines and Healthcare Products Regulatory Agency) advisor.

Christine N. Sang, M.D., M.P.H. – Clinical Advisory Board

Christine Sang, MD, MPH, FASA is an Associate Professor of Anaesthesia at Harvard Medical School, specializing in both pediatric and adult anesthesiology and acute and chronic pain management. She is the founding director of the Translational Pain Research program at Brigham and Women’s Hospital, which conducts Phases 1a (First-in-Human), 1b/2a (proof-of-concept) and 2b/3 analgesic clinical trials in a variety of pain states and in neurodegeneration. Dr. Sang continues to serve on numerous boards and committees for her institution, leading medical societies, government agencies, publications, nonprofit organizations, and patient advocacy. She is the founding chair of the Medical and Scientific Advisory Committee at United Spinal Association, and served on the board of Praxis Spinal Cord Institute where she was chair of the governance committee. She serves the Department of Health and Human Services as a scientific member of the Interagency Pain Research Coordinating Committee. Dr. Sang obtained her M.D. from the Johns Hopkins University School of Medicine, and her M.P.H. from Harvard T.H. Chan School of Public Health.

 Christine Allen, Ph.D. – Scientific Advisory Board

Christine Allen, Ph.D., is a full professor at the University of Toronto and an internationally recognized leader with more than 170 publications in drug formulation and development. She is a member of the Scientific Leadership Team of the Acceleration Consortium, a strategic initiative at the University of Toronto awarded $200M in funding from the Canada First Research Excellence Fund. She has received numerous awards and is a distinguished fellow of prestigious societies including the American Institute for Medical and Biological Engineering, and the Canadian Academy of Health Sciences. In addition, she is a co-founder and CEO of Intrepid Labs Inc., a company that is accelerating pharmaceutical drug development through integration of AI, automation and advanced computing. She is also a co-founder and board member at Nanovista Inc. Her lab at U of T is deeply engaged in industry partnerships, playing a key role in advancing drugs from early-stage research to clinical trials. Her leadership has been pivotal in several scientific societies, notably as President of the Controlled Release Society and the Canadian Society for Pharmaceutical Sciences. In academia, her roles have included the inaugural Associate Vice-President and Vice Provost Strategic Initiatives and Interim Dean of the Leslie Dan Faculty of Pharmacy. Dr. Allen’s commitment to equity, diversity and inclusion (EDI) goes beyond words. In 2019, she founded the Women in STEAM: Leading and Reading book club to create a community that supports women as they advance in their education and careers. She earned her Ph.D. in Chemistry from McGill University, and her Bachelor of Science from University of Ottawa.

Joachim Kohn, Ph.D. – Scientific Advisory Board

Joachim Kohn, Ph.D. is a distinguished professor emeritus at Rutgers University and the founder and principal investigator of the Kohn Lab, a laboratory dedicated to improving health care and quality of life by developing advanced biomedical products for tissue repair, replacement and the delivery of pharmaceutical agents. Dr. Kohn serves as the director of the New Jersey Center for Biomaterials and has been a principal investigator for numerous federally funded research and development programs. His research focuses on the development of new biomaterials, and he has won numerous awards and honors for his breakthrough studies. Dr. Kohn holds a bachelor’s degree from Hebrew University, a Ph.D. from Weizmann Institute, and completed a postdoctoral fellowship in polymeric drug delivery systems at the Massachusetts Institute of Technology. 

Louis Lazo Radulovic, Ph.D., M.P.H. – Scientific Advisory Board

Lous Lazo Radulovic, Ph.D., M.P.H., is an independent consultant who brings significant experience in pharmacokinetics/drug metabolism and toxicology. Previously, Dr Radulovic worked at Warner-Lamber/Parke-Davis and Pfizer for over 20 years, having held positions of increasing responsibility at both companies. He subsequently started a Michigan office for Fulcrum Pharma Developments, Inc, a multi-national drug development and regulatory consulting company. After leaving Fulcrum, Dr Radulovic founded two independent nonclinical consulting companies, Drug Development Preclinical Services, LLC and Innovative Pharma Consulting, LLC. His expertise spans medical devices, small molecules, and biologics across several therapeutic areas. Dr Radulovic has served on in-licensing/due diligence teams, conducted numerous gap analyses on nonclinical packages, and has extensive regulatory submission experience for CNS drugs and antihyperlipidemics. Dr Radulovic is a retired member of the Society of Toxicology and has served as a member of the editorial board of Drug Metabolism and Disposition. He was also an Adjunct Professor of Toxicology at The University of Michigan and is a graduate of the same institution.

Arthur Tipton, Ph.D. – Scientific Advisory Board

Arthur Tipton, Ph.D., is an independent consultant that aids companies in developing the next generation of drug delivery products. He previously held leadership roles in three drug delivery start-ups and played a key role in each company’s path to a public offering. He was founder and chief executive officer of Brookwood Pharmaceuticals, now part of Evonik. Dr. Tipton holds 43 U.S. patents; his inventive efforts have led to several publications and multiple commercial products. He currently serves as a board member for five organizations and has previous experience on 12 additional boards. His resume also includes induction into the National Academy of Inventors, the College of Fellows for the American Institute for Medical and Biological Engineering and the Controlled Release Society, where he served as president in 2015. Most recently, Dr. Tipton was elected to the National Academy of Engineering in 2021. He holds a Ph.D. in polymer science and engineering from the University of Massachusetts.

 About ATX101

ATX101 is a novel investigational configuration of an approved, well-characterized, validated intracellular sodium ion channel blocker, bupivacaine, and a biopolymer that has been designed to provide weeks of pain relief following total knee arthroplasty (TKA, or replacement), a common orthopedic surgery. ATX101 has a high density of drug within its small footprint to allow for ultra-sustained analgesia. It is placed in minutes at the end of standard surgery to deliver its analgesic effect over weeks before eventually dissolving into water and carbon dioxide. The simple procedure does not require specialized training and is intended to replace the existing complex mix of analgesic products used for shorter-term pain management in the post-surgical setting. ATX101 is an investigational product that has not been approved by the U.S. Food and Drug Administration.

About Allay Therapeutics

Allay Therapeutics is pioneering ultra-sustained analgesic products to transform post-surgical pain management and recuperation for patients and physicians. Our proprietary technology platform combines validated non-opioid analgesics and biopolymers to create dissolvable candidates to deliver pain relief within a targeted site over weeks: an order of magnitude greater than the longest-lasting pain treatments currently available. Our platform and vision were shaped by The Foundry incubator and Lightstone Venture’s Singapore Fund. Allay unites a dynamic, global team of entrepreneurs, scientists, clinicians and innovators in the San Francisco Bay Area and Singapore. Learn more at allaytx.com.

For further details, please contact:

 Investors
Adam Gridley
adam.gridley@allaytx.com

 Media
allay@tenbridgecommunications.com

•  Planned Phase 2b trial expected to enroll 200 participants at U.S. sites
• Study design and protocol informed by recent positive discussions with U.S. Food and Drug Administration
• Prior dose-ranging Phase 2b trial demonstrated durable treatment effects with ATX101 versus standard-of-care bupivacaine based on pain intensity out to four weeks, with less use of opioids for pain relief while achieving faster improvement in function

SAN JOSE, CA, June 12, 2024 (BUSINESSWIRE) —  Allay Therapeutics, a clinical-stage biotechnology company pioneering ultra-sustained analgesic products to transform post-surgical pain management and recuperation, today announced plans to proceed to a Phase 2b registration trial of its lead investigational product ATX101. The clinical trial builds on a strong foundation of clinical data from prior exploratory dose-ranging studies and is informed by recent discussions with the U.S. Food and Drug Administration (FDA) on the study design and protocol. If successful, this Phase 2b registration trial would support a new drug application (NDA) filed with the FDA.

“We’re excited to reach this important milestone following a productive dialogue with the FDA to establish a clear path forward to evaluating ATX101 and further demonstrating its potential as a post-surgical pain management therapeutic,” said Adam Gridley, Chief Executive Officer at Allay Therapeutics. “The encouraging data from our recently completed Phase 2b dose-ranging trial provide compelling support for our registration clinical trial design, and we look forward to working closely with investigators to fully assess ATX101’s impact on patient recovery and recuperation following total knee replacement.”

The Phase 2b registration trial of 200 participants undergoing total knee arthroplasty (replacement, or TKA surgery) will be conducted at multiple U.S. sites and is a three-arm randomized controlled study evaluating treatment with ATX101 1,500 mg versus placebo or a bupivacaine active comparator. The primary endpoint will be the area under the curve (AUC) of pain intensity as measured by the NRS-Rest over several weeks, with secondary endpoints evaluating reduction in use of opioids, opioid-related side effects, and improvement in physical function. The trial will assess and inform additional functional and health economics endpoints for an anticipated global Phase 3 registration study that would support an NDA filing.

Allay’s recently completed dose-ranging Phase 2b trial enrolled 112 participants before being concluded early based on a positive interim analysis. Data showed that ATX101 achieved sustained, clinically meaningful post-surgical pain relief for up to four weeks following TKA compared to the standard of care (SOC) active comparator, bupivacaine. Treatment with ATX101 resulted in a decrease in opioid use as well as a decrease in opioid-related side effects and meaningful improvements in functional activities up to 60 days following surgery.

About ATX101

ATX101 is a novel investigational configuration of an approved, well-characterized, validated intracellular sodium ion channel blocker, bupivacaine, and a biopolymer that has been designed to provide weeks of pain relief following total knee arthroplasty (TKA, or replacement), a common orthopedic surgery. ATX101 has a high density of drug within its small footprint to allow for ultra-sustained analgesia. It is placed in minutes at the end of standard surgery to deliver its analgesic effect over weeks before eventually dissolving into water and carbon dioxide. The simple procedure does not require specialized training and is intended to replace the existing complex mix of analgesic products used for shorter-term pain management in the post-surgical setting. ATX101 is an investigational product that has not been approved by the U.S. Food and Drug Administration.

About Allay Therapeutics

Allay Therapeutics is pioneering ultra-sustained analgesic products to transform post-surgical pain management and recuperation for patients and physicians. Our proprietary technology platform combines validated non-opioid analgesics and biopolymers to create dissolvable candidates to deliver pain relief within a targeted site over weeks: an order of magnitude greater than the longest-lasting pain treatments currently available. Our platform and vision were shaped by The Foundry incubator and Lightstone Venture’s Singapore Fund. Allay unites a dynamic, global team of entrepreneurs, scientists, clinicians and innovators in the San Francisco Bay Area and Singapore. Learn more at allaytx.com.

For further details, please contact:

Investors
Adam Gridley
adam.gridley@allaytx.com

Media
Chris Railey
chris@tenbridgecommunications.com
M: +1 617-834-0936

• Results inform design of pivotal Phase 2B study for potentially first ultra-sustained analgesic product
• Study concluded early for strong efficacy signals across multiple parameters
• Clinically meaningful reductions in patient pain relative to standard of care (SOC) observed at timepoints extending to 30 days following total knee replacement
• Greater reductions in opioid usage seen across four weeks, relative to SOC

SAN JOSE, CA, April 11, 2024 (BUSINESSWIRE) —  Allay Therapeutics, a clinical-stage biotechnology company pioneering ultra-sustained analgesic products to transform post-surgical pain management and recuperation, today announced the results from a Phase 2B clinical study of its lead investigational product ATX101. ATX101 achieved sustained post-surgical pain relief for up to four weeks for patients following total knee arthroplasty (replacement, or TKA surgery) and outperformed a standard of care (SOC) active comparator, bupivacaine, on durability of effect, use of opioids to support pain relief and the potential for patients to return to day-to-day activities earlier. The data informs the design of a pivotal Phase 2B study planned to start in 2024. If successful, this study would support a new drug application filed with the U.S. Food and Drug Administration.

ATX101 is a novel configuration of a bioresorbable polymer and bupivacaine, an approved injectable non-opioid analgesic drug routinely used in surgeries that provides only one day of pain relief. ATX101 contains a high density of bupivacaine within a biodegradable polymer designed to deliver an ultra-sustained analgesic effect over weeks before dissolving away.

“These results support the potential of ATX101’s ability to transform the post-surgical pain management paradigm by delivering non-opioid-based, ultra-sustained pain relief for weeks following knee replacement surgery. Its simple administration has the potential to replace complex and costly existing protocols while providing rapid and extended pain relief over weeks, thereby reducing the burden of these surgeries for patients, physicians and payors alike,” said David Hewitt, M.D., Chief Medical Officer of Allay Therapeutics. “With a growing body of supportive clinical data for ATX101 in TKA, we are highly encouraged regarding the other ultra-sustained product candidates in our portfolio. We thank our investigators, staff and participating patients for helping us deliver this important clinical milestone and gain clear guidance for the design of our pivotal clinical study as we move towards registration.”

The study was conducted at 13 sites in Australia, Canada, and the United Kingdom, and enrolled 112 of the planned 165 subjects before being concluded following an interim analysis showing strong efficacy signals related to both pain reduction and need for supplementary opioids relative to the standard of care. These signals were observable despite the modestly sized exploratory study that was not powered to demonstrate statistical significance. The data included:

• Rapid onset of action and efficacy with ATX101 comparable to bupivacaine SOC over the first 24 hours.
• A clear dose response on the Numerical Rating Scale for Pain at rest (NRS-R) over time, with clinically meaningful separation of the 1,500mg dose of ATX101 versus bupivacaine SOC through 1, 2 and 3 weeks.
• Clinically meaningful efficacy signals based on reductions on the primary endpoint, the NRS-R area under the curve (AUC) versus controls over 1, 2, 3 and 4 weeks. These differences reached a nominal significance of p<0.05 at multiple time points.
• Reduction in opioid consumption with ATX101 versus bupivacaine SOC from Day 2 onward, with more patients opioid-free at earlier time points.
• Meaningful improvements in a variety of key indicators of function (e.g. activities of daily living) through 30 and 60 days.
• ATX101 appears to be generally well tolerated with a comparable safety profile to bupivacaine SOC. The majority of treatment-emergent adverse events were categorized as mild or moderate.

The study compared a single administration of either 1,000 mg (n=37) or 1,500 mg (n=37) dose of ATX101 to a control group (saline placebo (n=4), or bupivacaine SOC (n=34)). Bupivacaine comparator was administered once via local infiltration or adductor canal block. To achieve the required dosage, two or three 500 mg ATX101 implants were placed within the knee capsule prior to surgical closure. The study employed a simplified analgesic regimen in which opioids were used as needed to treat postoperative pain. All patients received around-the-clock celecoxib and acetaminophen to simulate a real-world multimodal analgesic protocol.

These data follow an earlier Phase 1B/2A study of ATX101 after TKA surgery which was also concluded early based on efficacy, with top-level data announced in 2021. In addition, extensive nonclinical studies have demonstrated controlled delivery, safety and tolerability of ATX101.

“Our hope was that the data from this study would demonstrate that patients can mobilize and rehabilitate more quickly, without the challenges of today’s standard of care, which only provides one day of pain relief with variable results and leaves patients with limited, often opioid-based solutions to manage their pain,” said Prof. Hemant Pandit, M.D., Ph.D., an expert in hip and knee joint replacement surgery at the University of Leeds and Leeds Teaching Hospitals NHS Trust, United Kingdom, and a leading investigator in this study. “The simplicity of the ATX101 procedure, which takes only two minutes to place with no special training, also has no equivalent among today’s local analgesic options. Indeed, the data from this multi-center, multi-national study supports the ability of ATX 101 to consistently deliver pain relief over a prolonged period, reducing the need for use of opioids and shortening the time needed to recover, allowing patients to return to day-to-day activities earlier than expected.”

TKA surgery is performed over one million times each year in the United States and the number of procedures is growing rapidly with the aging population. It is associated with a lengthy, painful recovery often managed with significant opioid usage and associated adverse events. The total addressable market for post-TKA pain management in the United States is estimated to be approximately $1 billion. Currently, approved post-surgical pain products last only 3-4 days at most, are often challenging to administer consistently, deliver variable outcomes and are insufficient to fully support the days and weeks of recuperation. This often results in supplementary opioid use and extended recovery, all resulting in significant additional healthcare cost burdens as well as significant risk of opioid abuse and addiction.

About ATX101

ATX101 is a novel investigational configuration of an approved, well-characterized, validated intracellular sodium ion channel blocker, bupivacaine, and a biopolymer that has been designed to provide weeks of pain relief following total knee arthroplasty (TKA, or replacement), a common orthopedic surgery. ATX101 has a high density of drug within its small footprint to allow for ultra-sustained analgesia. It is placed in minutes at the end of standard surgery to deliver its analgesic effect over weeks before eventually dissolving into water and carbon dioxide. The simple procedure does not require specialized training and is intended to replace the existing complex mix of analgesic products used for shorter-term pain management in the post-surgical setting.  ATX101 is an investigational product that has not been approved by the U.S. Food and Drug Administration.

About Allay Therapeutics

Allay Therapeutics is pioneering ultra-sustained analgesic products to transform post-surgical pain management and recuperation for patients and physicians. Our proprietary technology platform combines validated non-opioid analgesics and biopolymers to create dissolvable candidates to deliver pain relief within a targeted site over weeks: an order of magnitude greater than the longest-lasting pain treatments currently available. Our platform and vision were shaped by The Foundry incubator and Lightstone Venture’s Singapore Fund. Allay unites a dynamic, global team of entrepreneurs, scientists, clinicians and innovators in the San Francisco Bay Area and Singapore. Learn more at allaytx.com.

For further details, please contact:

Investors
Adam Gridley
adam.gridley@allaytx.com

Media
Chris Railey
chris@tenbridgecommunications.com
M: +1 617-834-0936

SAN JOSE, CA & OSAKA, JAPAN, December 18, 2023 — Allay Therapeutics, Inc. (Allay) today announced that they have entered into a license agreement with Maruishi Pharmaceutical Co., Ltd. (Maruishi), providing Maruishi with exclusive rights to develop and commercialize Allay’s lead investigational drug candidate, ATX101, and other ultra-sustained analgesic implantable drug candidates for acute pain in Japan. ATX101 is a non-opioid, bupivacaine-based drug product designed to deliver continual, localized pain relief for weeks following total knee arthroplasty (replacement), or TKA, a common orthopedic surgery.   

Under the terms of the agreement, Allay will receive an upfront payment and an equity investment, and is eligible to receive future milestone payments related to pre-defined clinical and regulatory events in the U.S. and Japan as well as commercial milestones and royalties on sales in Japan. Allay retains the right to develop and commercialize ATX101 in all territories outside of Japan.  

“Maruishi is one of the leading specialty pharmaceutical companies in perioperative care and anesthetic settings, with strong development and commercial capabilities within the acute post-operative pain management arena,” said Adam Gridley, Chief Executive Officer of Allay. “We’re especially excited to partner with Maruishi given their similar mission to improve quality of life and ease post-surgical recovery. We believe that their internal expertise and long history with local anesthetic product R&D and strong relationships with key opinion leaders provide a natural fit to help accelerate the development of ATX101 and potentially deliver better pain management solutions for patients in Japan.”   

“We are pleased to initiate this development and commercialization collaboration with Allay. Their leadership and long history in Asia and the U.S. provide the opportunity to rapidly develop ATX101 and other platform products in their ultra-sustained delivery pipeline,” said Katsuhito Inoue, President and Representative Director of Maruishi. “We believe the ATX programs will complement our existing local anesthetic products in Japan, and provide our doctors and patients an attractive alternative to the existing therapies with longer pain relief and better recoveries from surgery.” 

 TKA surgery represents an estimated potential $1 billion market, which combined with the multi-billion dollar economic burden of opioid abuse underscores the critical need to reimagine the pain management paradigm. An open-label Phase 1b/2a study completed by Allay demonstrated ATX101’s potential to transform post-surgical pain management, with data supporting the potential for a strong safety profile and sustained pain relief lasting two weeks after administration. Allay is currently evaluating ATX101 in a randomized controlled Phase 2b study. The parties plan to advance ATX101 into the requisite registration studies in the US and Japan.  

Renexes LLC served as an advisor to Allay in connection with the transaction. Cooley LLP acted as legal counsel to Allay for the transaction.   

About ATX101 

ATX101 is a novel configuration of an approved, well-characterized, validated intracellular sodium ion channel blocker, bupivacaine, and a biopolymer that has been designed to provide weeks of pain relief following TKA. ATX101 has a high density of drug within its small footprint to allow for ultra-sustained analgesia. It is placed at the end of standard surgery, in minutes, to deliver its analgesic effect over weeks before dissolving into water and carbon dioxide over a longer period. On a Phase 1b/2a study, ATX101 demonstrated compelling delivery of drug over several weeks with a reduction in pain and opioid usage, and was generally well tolerated.   

About Allay Therapeutics, Inc. 

Allay is pioneering a new category of ultra-sustained pain therapeutics to transform post-surgical pain management and recuperation for patients and physicians. Allay’s proprietary technology platform combines validated non-opioid analgesics and biopolymers to create dissolvable therapeutics to deliver pain relief within a targeted site over weeks—an order of magnitude greater than the longest-lasting pain treatments currently available. The company’s lead investigational product candidate, ATX101, is currently being evaluated in a Phase 2 clinical study in TKA surgeries. Allay unites a dynamic, global team of entrepreneurs, scientists, clinicians and innovators in the San Francisco Bay Area and Singapore. Learn more at allaytx.com. 

About Maruishi Pharmaceutical Co., Ltd.   

Maruishi, an Osaka-based company which commenced operations in 1888, has a strong presence in the Japanese market as a specialty pharma developing, manufacturing, and marketing perioperative and infection control products, and as a leading producer of Japanese Pharmacopoeia drugs. Making use of the technology, knowledge, and know-how that have been cultivated over 130 years of history, Maruishi continues to contribute to the healthcare and improvement of QOL of the patients.  For further details, please visit https://www.maruishi-pharm.co.jp/english/.

 Investors 
Adam Gridley 
adam.gridley@allaytx.com 
 

Media 
Chris Railey 
chris@tenbridgecommunications.com 
M: +1 617-834-0936 

SAN JOSE, CA, SEPTEMBER 6, 2023 — Allay Therapeutics, a clinical-stage biotechnology company pioneering ultra-sustained analgesic products to transform post-surgical pain management and recuperation, today announced the appointment of Nicole Vitullo, venture partner at Arboretum Ventures, to its board of directors.

“We’re thrilled to have Nicole join the Allay board and appreciate the continued support of Arboretum Ventures as we work to change the pain management paradigm and dramatically improve the post-surgical recovery experience for patients,” said Adam Gridley, Chief Executive Officer of Allay Therapeutics. “Nicole’s counsel, drawing from her long experience working with advanced-stage and commercial-stage biopharma companies, will be invaluable as we continue clinical development of our lead candidate ATX101 and advance additional Allay products into clinical studies worldwide.”

Nicole is a longtime biotech investor and company advisor with extensive experience in both public and private investing, as a Partner with Domain Associates, a venture capital firm focused in the life sciences sector. She joined Arboretum as a venture partner in 2023. Nicole currently serves on the board of Esperion Therapeutics and Hinge Bio Inc. Her past board memberships include numerous companies that have entered transactions, including Achillion Pharmaceuticals (Alexion), Calixa Therapeutics (Cubist Pharmaceuticals), Celator Pharmaceuticals (Jazz Pharmaceuticals), Cerexa (Forest Laboratories), Durata Therapeutics (Actavis), Marinus Pharmaceuticals, Onyx Pharmaceuticals, and VentiRx Pharmaceuticals (Celgene). Nicole holds a bachelor’s degree in mathematics and MBA from the University of Rochester.

“I’m excited to be part of Allay’s mission to develop medicines that help patients through extended painful recoveries and reduce their reliance on opioids following surgery. There is a huge unmet need for therapies that not only provide pain relief but also offer peace of mind for patients and their caregivers,” said Ms. Vitullo. “I look forward to working with Adam and the team as they work to bring these innovations to patients, providers and payors.”

About Allay Therapeutics

Allay Therapeutics is pioneering a new category of ultra-sustained pain therapeutics to transform post-surgical pain management and recuperation for patients and physicians. Allay’s proprietary technology platform combines validated non-opioid analgesics and biopolymers to create dissolvable therapeutics to deliver pain relief within a targeted site over weeks—an order of magnitude greater than the longest-lasting pain treatments currently available. The company’s lead investigational product candidate, ATX101, is currently being evaluated in a Phase 2 clinical study in total knee arthroplasties (TKA, also called total knee replacements). Allay unites a dynamic, global team of entrepreneurs, scientists, clinicians and innovators in the San Francisco Bay Area and Singapore. Learn more at allaytx.com.

For further details, please contact:

Investors

Adam Gridley
adam.gridley@allaytx.com

Media

Chris Railey
chris@tenbridgecommunications.com
M: +1 617-834-0936

• Implants from the U.S. startup Allay Therapeutics are designed to relieve pain after knee surgery for up to three weeks
• Technology may reduce the need for opioid painkillers
• Polymers from Evonik are a key component

ESSEN, GERMANY and SAN JOSE, CALIF., USA, DECEMBER 13, 2022 – Evonik has invested in the biopharmaceutical company Allay Therapeutics. The U.S. and Singapore-based startup has developed an implant for treating pain after knee surgery. It is inserted directly into the knee and may relieve pain for up to three weeks – previous solutions work for a maximum of three days. The technology may promote the recovery process and make it possible to reduce or eliminate the administration of common opioid painkillers such as morphine or oxycodone. Biodegradable polymers from Evonik are the key to the success of this new type of pain therapy: they ensure that the active ingredients are delivered over a longer period.

Knee replacements are one of the most frequently performed surgeries worldwide. The consequences of the procedure are often painful with pain that lasts for weeks, hindering recovery. Therefore, doctors use painkillers such as opioids after these surgeries. However, they have numerous side effects, including a high risk of dependence. Allay’s products, which are in the early stages of clinical development, are expected to offer an alternative. “Our products may provide patients with pain relief exactly when they need it most – for weeks instead of days. This would significantly improve and accelerate the recovery process,” says Adam Gridley, Chief Executive Officer (CEO) of Allay Therapeutics.

Evonik sees great potential in this technology. “Allay’s pain products can become a game-changer in postoperative pain management. They may reduce the problems that opioids bring, such as dependence, further hospitalization, lengthy rehabilitation, and overall costs to the healthcare system,” says Bernhard Mohr, head of Evonik Venture Capital.

Allay’s products are thin implants about the size of a coin. They are placed around the implanted knee joint at the end of the surgery and consist of a proven local non-opioid anesthetic and polymers from Evonik. The local anesthetic blocks the transmission of pain signals to the spinal cord, thus stopping the pain impulse before it reaches the brain. Until now, the duration of such systems was limited to a few days. Allay has succeeded in extending the delivery to up to three weeks through a novel active ingredient-polymer architecture. Evonik’s polymers play a key role here: they ensure that the active ingredient is delivered in a controlled fashion over a long period. During this process, the implants gradually dissolve and are broken down by the body. The technology can be easily adapted for other orthopedic and soft tissue surgeries and Allay is currently developing a portfolio of products based on this drug-polymer architecture.

Evonik has more than 60 years of experience in technologies for the targeted delivery of medical agents. Its Health Care Business Line is a global innovation partner for the pharmaceutical industry. “We are pleased to be able to support our partner Allay in developing this promising innovation. It can fundamentally change pain management and take away patients’ fear of surgery,” says Paul Spencer, Head of the Drug Delivery & Products Product Line in Evonik’s Health Care Business Line.  Health Care supplies the biodegradable polymer processed in the Allay implant.

With more than 1.2 million knee joint interventions per year, the United States is the most relevant market for Allay’s technology. The volume for the treatment of very severe, postoperative pain is estimated at $10 billion. The dramatic increase in opioid addicts in the U.S., referred to as the opioid crisis, reinforces the relevance of alternative pain therapies.

Allay Therapeutics was founded in 2016. The company is headquartered in San Jose in the U.S. state of California with Research and Development facilities in Singapore, where the technology was developed. “We are delighted to have one of the world’s leading specialty chemical companies on our side with whom we can further develop our technology,” emphasizes Adam Gridley of Allay.

About Evonik

Evonik is one of the world leaders in specialty chemicals. The company is active in more than 100 countries around the world and generated sales of €15 billion and an operating profit (adjusted EBITDA) of €2,38 billion in 2021. Evonik goes far beyond chemistry to create innovative, profitable and sustainable solutions for customers. More than 33,000 employees work together for a common purpose: We want to improve life today and tomorrow.

About Evonik Venture Capital

With a fund size of €400 million, Evonik Venture Capital (EVC) has made 50 investments since 2012, both direct and fund investments. From its offices in Germany, the USA and China, EVC invests in innovative technologies and business models in the area of Nutrition & Care, Smart Materials and Specialty Additives. The investments also support the digitalization and sustainability strategy of Evonik. The scope ranges from early stage to growth stage with an investment volume of up to €15 million per portfolio company. https://venturing.evonik.com

Disclaimer

In so far as forecasts or expectations are expressed in this press release or where our statements concern the future, these forecasts, expectations or statements may involve known or unknown risks and uncertainties. Actual results or developments may vary, depending on changes in the operating environment. Neither Evonik Industries AG nor its group companies assume an obligation to update the forecasts, expectations or statements contained in this release.

About Allay Therapeutics

Allay Therapeutics is pioneering ultra-sustained analgesic products to transform post-surgical pain management and recuperation for patients and physicians. Our proprietary technology platform combines validated non-opioid analgesics and biopolymers to create dissolvable candidates to deliver pain relief within a targeted site over weeks: an order of magnitude greater than the longest-lasting pain treatments currently available. Our platform and vision were shaped by The Foundry incubator and Lightstone Venture’s Singapore Fund. Allay unites a dynamic, global team of entrepreneurs, scientists, clinicians and innovators in the San Francisco Bay Area and Singapore. Learn more at allaytx.com.

Evonik Contacts

Jörg Wagner
External Communications
Phone :  +49 201 177 3408
Mobile : +49 152 56 38 60 40
Joerg2.Wagner@evonik.com

Holger Seier
Research, Development & Innovation
Phone: +49 201 177 2222
Mobile: +49 151 538 31577
Holger.Seier@evonik.com

Allay Therapeutics Contacts

Investors

Adam Gridley
adam.gridley@allaytx.com

Media

Chris Railey
chris@tenbridgecommunications.com
Mobile: +1 617-834-0936

MENLO PARK, CA, JANUARY 27, 2022 — Allay Therapeutics, a clinical-stage biotechnology company pioneering ultra-sustained analgesic products to transform post-surgical pain management and recuperation, today announced the appointment of Ron Burch, M.D., Ph.D. to its Scientific Advisory Board. Dr. Burch brings significant experience in the development and commercialization of drug delivery and pain management therapeutics.

“I am excited to welcome Dr. Burch to the Allay team. He is an industry expert and clinician whose background blends biomedical research, product development and commercialization, and he has worked on many of the seminal pain management products that are currently available,” said Adam Gridley, Chief Executive Officer of Allay Therapeutics. “His counsel will be invaluable as we progress our pipeline of potentially transformative ultra-sustained analgesic products.”

Dr. Burch currently serves as Chief Executive Officer of Sanguistat, a company developing products to treat bleeding disorders. He previously served as Chief Medical Officer at Naurex, a clinical-stage biopharmaceutical company developing novel NMDA receptor modulators, and Pacira, an industry leader in non-opioid solutions for pain. Dr. Burch has served as Chairman of Zeneca Pharmaceuticals’ Global CNS Therapeutics Area Team; co-founder and CEO of AlgoRx Pharmaceuticals, a company that successfully developed a number of therapeutic agents for pain management; CEO and Chairman of Biowave Corporation, a medical device company that successfully launched three neurostimulation products to treat chronic, intractable pain and postoperative pain; and Scientific Advisor of Collegium Pharmaceuticals. He also held various managerial positions with Purdue Pharma, including Vice President of Scientific Evaluations and Immunotherapeutics, Medical Director and Project Manager and Medical Safety Officer for several pain development programs. Dr. Burch was a researcher at the National Institutes of Health, performing research involving neuroreceptor regulation with Nobel Laureate Dr. Julius Axelrod. Dr. Burch obtained a Ph.D. in Pharmacology and M.D. from the Medical University of South Carolina. He holds B.S. degrees in chemistry and marine biology from the College of Charleston.

“Allay is engaging in innovative work to bring about a dramatic transformation in how we guide patients through post-surgical pain management,” said Dr. Burch. “The company’s proprietary technology platform holds tremendous potential to develop a suite of products offering a non-opioid solution to some of the most difficult post-surgical recoveries.”

Allay’s advisory boards also include David Dalury, M.D., an orthopedic surgeon and educator specializing in knee and hip replacement, leading the Company’s Clinical Advisory Board; and scientific advisors Joachim Kohn, Ph.D., a researcher focused on the development of new biomaterials; and Arthur Tipton, Ph.D., a biopharma veteran with extensive drug development experience.

About Allay Therapeutics
Allay Therapeutics is pioneering ultra-sustained analgesic products to transform post-surgical pain management and recuperation for patients and physicians. Our proprietary technology platform combines validated non-opioid analgesics and biopolymers to create dissolvable candidates to deliver pain relief within a targeted site over weeks: an order of magnitude greater than the longest-lasting pain treatments currently available. Our platform and vision were shaped by The Foundry incubator and Lightstone Venture’s Singapore Fund. Allay unites a dynamic, global team of entrepreneurs, scientists, clinicians and innovators in the San Francisco Bay Area and Singapore. Learn more at allaytx.com.

For further details, please contact:

Investors
Adam Gridley
adam.gridley@allaytx.com

Media
Chris Railey
chris@tenbridgecommunications.com
M: +1 617-834-0936

MENLO PARK, CA, JANUARY 6, 2022 —  Allay Therapeutics, a clinical-stage biotechnology company pioneering ultra-sustained analgesic products to transform post-surgical pain management and recuperation, today announced that it has established its corporate headquarters in San Jose, California and expanded its base of operations in Singapore.

The new headquarters, located at BioSquare, a Silicon Valley life sciences park in North San Jose, will house administrative, research and development, clinical and operations functions supporting Allay’s technology platform and product development pipeline. The 50,000 square foot Allay headquarters will accommodate Allay’s global workforce, which has nearly doubled over the last year, and its planned growth in the U.S. and Singapore. Allay also doubled its Singapore footprint with the renewal and expansion of its R&D and operations facilities in the Singapore Science Park, a leading life sciences and innovation campus. Allay plans to occupy both the U.S. site and the expanded Singapore facility by spring 2022 and complete the build-out of laboratory space in its headquarters by fall 2022.

“We’re pleased to establish a permanent presence in the talent-rich Bay Area and to expand the global facilities supporting the burgeoning pipeline led by our Singapore based team members. The new headquarters is designed to enable full integration of our research, manufacturing and pipeline development activities across our global teams, and is a testament to our significant growth as a company over the last year,” said Adam Gridley, Chief Executive Officer of Allay Therapeutics. “We’re grateful for the continued support of our investor group and our medical advisors, and believe we are well positioned to advance revolutionary pain management products from our pipeline supported by a growing world-class team with cutting-edge facilities and technology.”

About Allay Therapeutics

Allay Therapeutics is pioneering ultra-sustained analgesic products to transform post-surgical pain management and recuperation for patients and physicians. Our proprietary technology platform combines validated non-opioid analgesics and biopolymers to create dissolvable candidates to deliver pain relief within a targeted site over weeks: an order of magnitude greater than the longest-lasting pain treatments currently available. Our platform and vision were shaped by The Foundry incubator and Lightstone Venture’s Singapore Fund. Allay unites a dynamic, global team of entrepreneurs, scientists, clinicians and innovators in the San Francisco Bay Area and Singapore. Learn more at allaytx.com.

For more information, please contact:

Investors

Adam Gridley
adam.gridley@allaytx.com

Media

Chris Railey
chris@tenbridgecommunications.com
M: +1 617-834-0936

• Financing led by Arboretum Ventures. Managing Partner Nicole J. Walker to join Allay Therapeutics Board of Directors
• ATX-101 to advance to Phase 2b development in total knee replacement surgeries in 2021
• Financing will also support broader development of ATX platform for ultra-sustained pain relief

MENLO PARK, CA, SEPTEMBER 15, 2021 (BUSINESSWIRE) —  Allay Therapeutics, a clinical-stage biotechnology company pioneering ultra-sustained analgesic products to transform post-surgical pain management and recuperation, today announced the completion of its oversubscribed $60M Series C financing, led by Arboretum Ventures. Participating in the round were NEA, Temasek, Pavilion Capital, Brandon Capital Partners, Vertex Growth, Vertex Ventures HC and WTT Investment Ltd. The proceeds from the Series C will advance the Company’s lead candidate, ATX-101, into Phase 2b clinical trials, and support the further development of Allay’s platform for ultra-sustained analgesic products.

“We’re pleased to attract such an impressive syndicate of healthcare investors to this round, and we’re fortunate to partner with Nicole and the Arboretum Ventures team to advance the Allay platform of products through clinical development. The vote of confidence by these investors is gratifying as we pursue our goal of allaying patients’ fears of extended painful recoveries and reliance on opioids after surgery,” said Adam Gridley, Chief Executive Officer of Allay Therapeutics. “We share a common belief that our underlying platform of tunable product candidates will change the way that patients, physicians and payors manage pain and will reduce costs to the overall healthcare system.”

Allay intends to proceed into a Phase 2b study of ATX-101 in total knee arthroplasties (TKA, also called total knee replacements) in the United States. Beyond ATX-101, Allay’s R&D teams in Singapore and the Bay Area have developed proof-of-concept of new implant variants, injectable formulations, formulations to permit patient self-dosing ‘on demand’ and formulations that incorporate a variety of small molecules and other local analgesics. The Company intends to advance at least one new clinical candidate into clinical trials each year and is currently building out its manufacturing capabilities in the Bay Area to support future product launches.

“Demand for total knee replacement surgery is growing dramatically, and with it, desire for non-opioid solutions providing lasting pain relief. We believe that Allay’s technology platform offers unprecedented potential breadth in terms of applicability and therapeutic profile for pain management, an area in need of innovation,” said Nicole J. Walker, Managing Partner, Arboretum Ventures. “Allay combines strong science, a veteran team and a clear vision for advancing an array of new products.”

 About Allay Therapeutics

Allay Therapeutics is pioneering ultra-sustained analgesic products to transform post-surgical pain management and recuperation for patients and physicians. Our proprietary technology platform combines validated non-opioid analgesics and biopolymers to create dissolvable candidates to deliver pain relief within a targeted site over weeks: an order of magnitude greater than the longest-lasting pain treatments currently available. Our platform and vision were shaped by The Foundry incubator and Lightstone Venture’s Singapore Fund. Allay unites a dynamic, global team of entrepreneurs, scientists, clinicians and innovators in the San Francisco Bay Area and Singapore. Learn more at allaytx.com.

For further details, please contact:

Investors

Adam Gridley

adam.gridley@allaytx.com

Media

Chris Railey

chris@tenbridgecommunications.com

M: +1 617-834-0936

MENLO PARK, Cali., July 8, 2021— Allay Therapeutics, a clinical-stage biotechnology company pioneering ultra-sustained analgesic products to transform post-surgical pain management and recuperation, today announced the appointment of David Hewitt, M.D. as chief medical officer. Dr. Hewitt is an accomplished neurologist and clinical trialist with over two decades of experience in clinical development and medical affairs. He joins Allay from Nura Bio, where he served as senior vice president, clinical development.

“I am pleased to welcome David to Allay. He is a leader in the field of analgesic drug development and his expertise and track record of success in the pain management and drug delivery space will be invaluable as we progress our lead therapeutic candidate into Phase 2b trials,” said Adam Gridley, chief executive officer of Allay Therapeutics. “We believe ATX-101 may establish a new category in post-surgical pain management providing extended pain relief with the potential for improved recovery. Providing pain relief beyond the first few days after surgery represents a significant unmet need for patients, caregivers and healthcare providers. David’s experience as a clinician and an industry leader will help establish this new category of pain management as we advance these new products to market.”

Prior to his role at Nura Bio, Dr. Hewitt was senior vice president of clinical development at Karuna Therapeutics, working on a novel mechanism for the treatment of schizophrenia. Dr. Hewitt previously served as chief medical officer at Syneos Health, leading a large medical affairs team focused on helping biopharmaceutical companies bring their novel therapies from lab to life. Prior to his role with Syneos Health, Dr. Hewitt held roles of increasing responsibility in the neurology group at Merck, working in pain, migraine and neurodegenerative diseases. Dr. Hewitt began his biopharma career in the Ortho-McNeil division of Johnson & Johnson, where he designed and conducted clinical trials focused on acute and chronic pain. He earned his medical degree from the University of Rochester School of Medicine & Dentistry and completed his neurology residency training at New York Hospital Cornell Medical Center before completing a fellowship in pain, palliative care and analgesic research at Memorial Sloan-Kettering Cancer Center.

“Allay’s ultra-sustained method of drug delivery may offer a promising non-opioid pain management approach to patients that will aid them in their recovery from surgery. I’m excited to join the Allay team in building on the initial promising clinical data showing reductions in pain and opioid usage over weeks,” said Dr. Hewitt. “At Allay, we are working to usher in a new era of pain management focused on providing analgesia in the weeks following surgery to improve functional recovery and potentially eliminate the use of narcotics as the primary therapy for postoperative pain.”

 About Allay Therapeutics

Allay Therapeutics is pioneering ultra-sustained analgesic products to transform post-surgical pain management and recuperation for patients and physicians. Our proprietary technology platform combines validated non-opioid analgesics and biopolymers to create dissolvable candidates to deliver pain relief within a targeted site over weeks: an order of magnitude greater than the longest-lasting pain treatments currently available. Our platform and vision were shaped by The Foundry incubator and Lightstone Venture’s Singapore Fund. Allay unites a dynamic, global team of entrepreneurs, scientists, clinicians and innovators in the San Francisco Bay Area and Singapore. Learn more at allaytx.com.

For further details, please contact:

Investors

Adam Gridley

adam.gridley@allaytx.com

Media

Chris Railey

chris@tenbridgecommunications.com

M: +1 617-834-0936

– First clinical data to demonstrate non-opioid pain relief lasting two weeks after one administration, where current post-surgical pain products are effective for a maximum of three days

– Significant reductions in pain and opioid usage relative to standard of care

– Clinical candidate for support of total knee replacement surgery, ATX-101, to move into Phase 2b clinical study this year

– Proprietary technology platform expanding to deliver a new category of ultra-sustained localized pain products for diverse conditions

MENLO PARK, Cali., May 13, 2021— Allay Therapeutics, a clinical-stage biotechnology company pioneering ultra-sustained analgesic products to transform post-surgical pain management and recuperation, today announced the first-ever clinical data showing non-opioid pain relief lasting two weeks after a single administration. Current post-surgical pain products have shown effectiveness for a maximum of three days after a single dose. The data come from a Phase 1b/2a clinical study of Allay’s first candidate, ATX-101, in development to treat pain after total knee arthroplasty (replacement), or TKA, surgery. TKA surgery is performed over one million times each year in the United States and is associated with a lengthy, painful recovery often managed with significant opioid usage. ATX-101 is a small dissolvable product candidate incorporating the validated local analgesic bupivacaine. It is designed to be incorporated into surgery to deliver continual, localized pain relief that matches the pain trajectory patients typically experience after TKA surgery.

Allay Therapeutics was formed with a singular goal: to allay patients’ fears of extended painful recoveries and reliance on opioids after surgery. Allay’s technology platform combines validated local analgesics and biopolymers in dissolvable candidates designed to deliver pain relief within a targeted site over days to weeks, or longer. Changes to the drug-biopolymer configuration and manufacturing process allow tuning of the amount of drug delivered and differing rates of release for each product candidate. This tunability permits a wide range of potential therapeutic profiles for different kinds of pain.

“Pain management innovation has stalled for too long in the face of the enormous need created by the opioid crisis and a growing number of patients undergoing painful surgeries where rapid recuperation is crucial for long-term outcomes. Allay was founded to deliver a gentler longer-term recovery for patients and ease the burden of pain management and opioid use for the healthcare system,” said Adam Gridley, chief executive officer of Allay Therapeutics. “We believe these unprecedented clinical data could be the start of a new era of ultra-sustained pain management. Our focus now is a Phase 2b trial of ATX-101 to enroll over 300 patients in the United States, as well as the advancing of our pipeline across several new areas of pain representing major unmet needs globally.”

Currently, approved post-surgical pain products using local anesthetics have demonstrated effectiveness for a maximum of three days. They are often challenging to administer consistently and have variable outcomes. They are insufficient to fully support recuperation, which often results in supplementary opioid use, readmissions and extended recovery, all resulting in significant additional healthcare costs. Opioids are short-term medications which act systemically on the body and have a range of side effects – including respiratory depression, greater pain sensitivity and the significant risk of abuse and addiction – which have fueled a major health crisis in the United States and beyond.

The recently completed Phase 1b/2a clinical study of ATX-101 was an open-label dose-ranging study at two Australian clinical sites which evaluated 22 patients undergoing TKA with ATX-101 implants incorporating approximately 250 mg, 750 mg and 1,500 mg doses of bupivacaine, respectively, of which 15 patients received the 1,500 mg dosage. The study was designed to evaluate safety and pharmacokinetics of ATX-101 in adult subjects in primary unilateral TKA while also examining dose response, pain scores, opioid use and overall impact on quality of life during recuperation. Originally planned to enroll up to 30 patients with up to 2,000 mg doses, the study was concluded early based on achieving compelling pain reduction and opioid use reduction data with only 1,500 mg.

The preliminary summary study outcomes include:

1. Over 14 days, the cohort treated with 1,500 mg of ATX-101 took between half to two-thirds less opioids than a typical TKA patient, and 80% were off opioids at the end of that period relative to approximately 50% for the standard of care, according to published literature.
2. In the same cohort, ATX-101 significantly outperformed the standard of care throughout the 14-day period for both the duration and magnitude of effect, using proprietary data sets of pain scores from clinical trials after TKA surgery. In this study, ATX-101 kept patients’ post-surgical pain in the zero or mild range for at least 14 days, relative to the published standard of care that typically results in severe short-term pain followed by moderate pain lasting for weeks. The standard of care includes various repeatedly dosed medications, including opioids.
3. ATX-101 delivered highly predictable dose responses across all three cohorts. It showed a clear linear relationship through the 14-day period between dose and maximum systemic concentration, as well as between dose and pharmacokinetic area under the curve, which represents total exposure to drug (R2 > 0.98). Predictable dynamics of drug delivery are a necessary property for therapeutic products like ATX-101 to support confidence in dosing selection.
4. ATX-101 delivered meaningful continual dosing throughout the 14-day period studied. During the acute phase of 0-4 days, comparable levels of bupivacaine were delivered by ATX-101 as compared to competitor products in published TKA studies. According to published literature, all other approved approaches using bupivacaine in TKA are no longer detectable five days after administration, whereas ATX-101 showed meaningful systemic levels through 14 days.
5. ATX-101 was observed to be generally well-tolerated in the study and no serious adverse events related to the product were seen.

“These data suggest an exciting therapeutic profile very different from anything in the current surgical pain management toolkit. The standard of care struggles to adequately serve patients in settings like TKA, which typically involves significant short-term and longer-term pain across a lengthy recuperation period,” said David Dalury, M.D., clinical professor of orthopedic surgery at the University of Maryland School of Medicine and Chief of Orthopedics at the University of Maryland St. Joseph Medical Center. “In orthopedic surgery, we are looking for simple, non-opioid solutions with consistent outcomes beyond two to three days that help patients return to normal function faster, to support earlier discharges and reduced need for ongoing clinical management. ATX-101 has made a promising step towards these goals and I look forward to further clinical data.”

Beyond ATX-101, Allay has developed proof-of-concept of new implant variants, injectable formulations, formulations to permit patient self-dosing ‘on demand’ and formulations that incorporate a variety of small molecules and other local analgesics.

Allay Therapeutics was founded in 2017 by The Foundry incubator and Lightstone Ventures’ Singapore fund. Following the acquisition of polymer innovator Orchid Medical in 2018, the company initiated pre‑IND discussions with the FDA and in 2019 completed a $25 million Series B financing led by NEA, with additional participation by Lightstone Ventures and Brandon Capital Partners.

Allay intends to proceed into a Phase 2b study of ATX-101 in the United States in 2021 and pursue regulatory filings with the United States Food and Drug Administration to support the Phase 2b study and a future potential Phase 3 clinical study, with a targeted NDA submission in 2024.

About ATX-101: In development to treat pain following total knee replacement surgery

ATX-101 is a novel configuration of an approved, well-characterized, validated intracellular sodium ion channel blocker, bupivacaine, and a biopolymer that has been designed to provide weeks of pain relief following total knee arthroplasty (replacement), or TKA, a common orthopedic surgery. ATX-101 has a high density of drug within its small footprint to allow for ultra-sustained analgesia. It is placed at the end of standard surgery, in minutes, to deliver its analgesic effect over weeks before dissolving into water and carbon dioxide over a longer period.

Summary outcomes from a Phase 1b/2a clinical study of ATX-101 demonstrated sustained pain relief lasting at least two weeks, with significant outperformance of historical pain relief scores provided by other approaches following TKA. Across all clinical and preclinical studies, ATX-101 appears to be well-tolerated with minimal systemic exposure, with no serious adverse events.

TKA recuperation is currently managed with short-term products that offer only up to two or three days of pain relief and are highly variable in impact, and as a result are often supplemented with opioids. These current treatments do not adequately support the patient’s early ‘breakthrough pain’ period or subsequent rehabilitation. Where local anesthetics are used, they can involve complex procedures that are difficult to administer consistently and to the precise site of pain. The United States alone currently sees over one million TKAs annually with an annual growth rate of 20%, creating a strong need for non-opioid solutions to facilitate outpatient procedures and longer-term recuperation.

About Allay Therapeutics

Allay Therapeutics is pioneering ultra-sustained analgesic products to transform post-surgical pain management and recuperation for patients and physicians. Our proprietary technology platform combines validated non-opioid analgesics and biopolymers to create dissolvable candidates to deliver pain relief within a targeted site over weeks: an order of magnitude greater than the longest-lasting pain treatments currently available. Our platform and vision were shaped by The Foundry incubator and Lightstone Venture’s Singapore Fund. Allay unites a dynamic, global team of entrepreneurs, scientists, clinicians and innovators in the San Francisco Bay Area and Singapore. Learn more at allaytx.com.

For further details, please contact:

Investors

Adam Gridley
adam.gridley@allaytx.com

Media

Chris Railey
chris@tenbridgecommunications.com
M: +1 617-834-0936

Literature references:

• Bramett et al. The Knee. 19 (2012) 530-536.
• Lachiewicz et al. The Journal of Arthroplasty. 35 (2020) 2843-2851.
• Marino et al. The Journal of Arthroplasty. 34 (2019) 495-500.
• Runner et all. The Journal of Arthroplasty. 35 (2020) S158-S162.
• Ruddell et al. JBJS. 00 (2020) 1-9.
• Clinical trial data on file with company.