• Breakthrough Therapy designation supported by results from a Phase 2 dose-ranging trial
• Planned Phase 2B registrational trial expected to enroll 200 participants at U.S. sites

Allay Therapeutics, a clinical-stage biotechnology company pioneering ultra-sustained analgesic products to transform post-surgical pain management and recuperation, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for its lead investigational product ATX101 for treatment of postsurgical pain following TKA procedures in adults. This BTD was granted based on clinical data from a Phase 2 exploratory dose-ranging trial for the treatment of Post-Surgical Pain following Total Knee Arthroplasty (TKA), or replacement.

“We’re delighted that the FDA granted Breakthrough Therapy designation for ATX101, which we believe recognizes the clear unmet need for novel non-opioid therapies that may provide extended pain relief to patients in the weeks following TKA surgeries. Despite decades of development efforts, current treatment methods provide only a few days of pain relief with complicated treatment regimens. ATX101 is designed to provide patients weeks of pain relief enabling an active recovery with less opioids used and less opioid-related side effects and risks,” stated Sharon Hall, SVP of Regulatory Affairs at Allay Therapeutics. “This BTD will allow us to work closely with the FDA to efficiently advance the ATX101 development program through its clinical and regulatory milestones, and eventual NDA filing. Our planned Phase 2B registrational trial will start early next year with leading investigative pain centers in the U.S. to fully assess ATX101’s potential impact on patient’s pain and recovery following painful total knee replacement surgeries.”

The BTD is supported by Allay’s recently completed dose-ranging Phase 2 exploratory trial (n=112) of ATX101 as compared to (SOC) active comparator, bupivacaine. 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. 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 and satisfaction up to 60 days following surgery.

FDA’s Breakthrough Therapy program is designed to expedite development review of drugs intended to treat a serious or life-threatening condition for which preliminary clinical evidence indicates the drug may demonstrate substantial improvement over available therapies. Under the designation, the FDA provides intensive guidance, organizational commitment involving senior managers, and eligibility for rolling review and other actions to expedite review. To learn more about Breakthrough Therapy designation, click here.

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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