Pharma Focus America

Allay Therapeutics Gets FDA Approval for IND Application to Launch Phase 2B Study of ATX101 for Treating Pain After Knee Surgery

Thursday, June 13, 2024

Allay Therapeutics, a clinical-stage biotechnology company, has announced its intention to advance to a Phase 2b registration trial for its leading investigational product, ATX101. This trial will be based on solid data from previous studies and will follow recent discussions with the U.S. Food and Drug Administration (FDA) about the study design and protocol. If successful, this Phase 2b trial could support the filing of a new drug application (NDA) with the FDA.

Adam Gridley, CEO of Allay Therapeutics, expressed excitement about this important step forward. He noted that the constructive discussions with the FDA have clarified the path for evaluating ATX101's potential in post-surgical pain management. The promising outcomes from a recent Phase 2b dose-ranging trial underscore the trial design for the registration study, and the company looks forward to collaborating with investigators to comprehensively evaluate ATX101's impact on recovery following total knee replacement surgery.

The planned Phase 2b registration trial will involve 200 participants undergoing total knee arthroplasty and will take place at multiple sites across the United States. This trial will be a three-arm randomized controlled study comparing the effects of ATX101 at 1,500 mg against a placebo and an active comparator, bupivacaine. The main outcome measure will be the area under the curve (AUC) for pain intensity, as measured by the NRS-Rest over several weeks. Secondary outcomes will assess the reduction in opioid use, the frequency of opioid-related side effects, and improvements in physical function. The findings from this trial will also inform additional functional and health economics endpoints for a future global Phase 3 registration study supporting an NDA submission.

In a previous dose-ranging Phase 2b trial involving 112 participants, the study concluded early due to positive interim results. These results demonstrated that ATX101 provided sustained, clinically meaningful pain relief for up to four weeks after surgery, surpassing the effects of the standard treatment, bupivacaine. Patients treated with ATX101 reported lower opioid usage and fewer opioid-related side effects, along with significant improvements in physical function lasting up to 60 days post-surgery.

ATX101 is an experimental formulation that combines an established intracellular sodium ion channel blocker, bupivacaine, with a biopolymer. Designed to provide extended pain relief following total knee arthroplasty, ATX101 aims to streamline pain management in the post-surgical environment. It is administered during the standard surgical procedure to deliver its effects over several weeks before breaking down into water and carbon dioxide. ATX101 is still under investigation and has not yet received approval from the FDA.



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