FDA Approves Allay Therapeutics' IND for Phase 2B Trial of ATX101 for Post-Surgical Knee Pain

Allay Therapeutics, a biotechnology company in the clinical stage, is pushing forward with a Phase 2b registration trial for their leading investigational product, ATX101. This move is underpinned by substantial clinical data from previous exploratory dose-ranging studies and follows recent discussions with the U.S. Food and Drug Administration (FDA) regarding the study design and protocol. If the trial proves successful, it could pave the way for a new drug application (NDA) to be filed with the FDA.

Adam Gridley, the CEO of Allay Therapeutics, expressed enthusiasm about reaching this significant milestone. He highlighted the productive discussions with the FDA that helped establish a clear direction for evaluating ATX101. The promising data from the recently concluded Phase 2b dose-ranging trial underpin the design of this new registration trial, and the company is eager to collaborate with investigators to fully assess the impact of ATX101 on patient recovery post-total knee replacement.

The upcoming Phase 2b registration trial will involve 200 participants undergoing total knee arthroplasty (TKA) and will be conducted at various sites across the U.S. This trial will be a three-arm randomized controlled study. It will compare the effects of ATX101 at a 1,500 mg dose against a placebo and a bupivacaine active comparator. The primary endpoint will focus on the area under the curve (AUC) of pain intensity measured by the NRS-Rest over several weeks. Secondary endpoints will consider the reduction in opioid use, side effects related to opioids, and improvement in physical function. Additionally, the trial will evaluate functional and health economics endpoints to inform a potential global Phase 3 registration study, which would support an NDA filing.

The previously completed dose-ranging Phase 2b trial involved 112 participants and was concluded early due to a positive interim analysis. The data revealed that ATX101 provided sustained and clinically significant post-surgical pain relief for up to four weeks following TKA, in comparison to the standard of care (SOC) active comparator, bupivacaine. This treatment with ATX101 also led to a reduction in opioid usage and related side effects, along with notable improvements in functional activities up to 60 days post-surgery.

ATX101 is a new investigational configuration of a well-established intracellular sodium ion channel blocker, bupivacaine, combined with a biopolymer designed to offer prolonged pain relief following total knee arthroplasty (TKA). This common orthopedic surgery often necessitates effective pain management. ATX101’s design includes a high density of the drug within a small footprint, allowing for ultra-sustained analgesia. It can be placed in minutes at the end of standard surgery to provide weeks of pain relief, eventually dissolving into water and carbon dioxide. This straightforward procedure does not require specialized training and aims to replace the complex mix of analgesic products currently used for shorter-term post-surgical pain management. However, ATX101 remains an investigational product and has not yet received approval from the U.S. Food and Drug Administration.

Allay Therapeutics is dedicated to revolutionizing post-surgical pain management and recuperation. Their innovative technology platform combines validated non-opioid analgesics with biopolymers to create dissolvable candidates that deliver pain relief at a targeted site for weeks, far surpassing the duration of current pain treatments. The company's approach and vision have been significantly shaped by The Foundry incubator and Lightstone Venture’s Singapore Fund. Allay Therapeutics brings together a global team of entrepreneurs, scientists, clinicians, and innovators based in the San Francisco Bay Area and Singapore.