FDA Grants Breakthrough Therapy Designation to Allay Therapeutics' ATX101 for Post-surgical Knee Pain

SAN JOSE, Calif.--(BUSINESS WIRE)--Allay Therapeutics, a biotechnology company in the clinical stage, has received Breakthrough Therapy designation (BTD) from the U.S. Food and Drug Administration (FDA) for its leading investigational product, ATX101, aimed at treating postsurgical pain after Total Knee Arthroplasty (TKA) procedures in adults. This designation follows clinical data derived from a Phase 2 exploratory dose-ranging trial focused on post-surgical pain treatment after knee replacement surgeries.

Sharon Hall, Senior Vice President of Regulatory Affairs at Allay Therapeutics, expressed the company's excitement about the FDA's decision to grant ATX101 the BTD status. Hall highlighted the pressing need for innovative non-opioid therapies capable of offering extended pain relief in the weeks following TKA surgeries. Current treatments typically provide only short-term relief and involve complex regimens. In contrast, ATX101 aims to offer weeks of pain relief, potentially leading to active recovery with reduced opioid use and fewer associated side effects and risks.

The BTD status allows for closer collaboration with the FDA. Allay Therapeutics plans to initiate a Phase 2B registrational trial early next year at key investigative pain centers in the U.S. to thoroughly evaluate the impact of ATX101 on pain and recovery following knee replacement surgeries.

The BTD is supported by the results of Allay’s recently concluded dose-ranging Phase 2 exploratory trial, which included 112 participants. The trial compared ATX101 to the standard of care (SOC) active comparator, bupivacaine. The data demonstrated that ATX101 provided sustained, clinically significant pain relief for up to four weeks post-TKA, surpassing the standard care. Furthermore, the use of ATX101 led to a reduction in opioid consumption as well as fewer opioid-related side effects, and patients reported significant improvements in functional activities and satisfaction up to 60 days post-surgery.

FDA's Breakthrough Therapy program aims to accelerate the development and review of drugs intended for serious or life-threatening conditions. The program is designed to help drugs that show preliminary clinical evidence of substantial improvement over existing therapies. With the BTD, the FDA provides intensive guidance, organizational commitment involving senior managers, and eligibility for rolling reviews and other expedited actions.

ATX101 is an innovative investigational formulation combining an approved, well-characterized intracellular sodium ion channel blocker, bupivacaine, and a biopolymer. This combination is designed to deliver pain relief for several weeks following TKA, a common orthopedic surgery. The formulation of ATX101 ensures a high drug density within a small area, allowing for long-term analgesia. It is administered in minutes at the end of the standard surgery and gradually dissolves into water and carbon dioxide. This simple procedure does not require specialized training and is intended to replace the existing mix of analgesic products used for short-term pain management after surgery. However, it is important to note that ATX101 is still an investigational product and has not been approved by the FDA.

Allay Therapeutics aims to revolutionize post-surgical pain management and recovery through its ultra-sustained analgesic products. The company's proprietary technology platform integrates validated non-opioid analgesics and biopolymers to create dissolvable candidates that provide pain relief at a targeted site over several weeks. This duration is significantly longer than any currently available treatments. The platform and vision of Allay Therapeutics were developed with the support of The Foundry incubator and Lightstone Venture’s Singapore Fund. The company comprises a global team of entrepreneurs, scientists, clinicians, and innovators based in the San Francisco Bay Area and Singapore.