Allay Therapeutics Announces FDA Acceptance of Investigational New Drug (IND) Application to Initiate Pivotal Phase 2B Trial of ATX101 for the Treatment of Post-Surgical Pain Following Total Knee Replacement Surgery

• 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, Calif.--(BUSINESS WIRE)-- 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.

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