The US Food and Drug Administration (FDA) has granted clearance to Allay Therapeutics’ investigational new drug (IND) application to initiate a Phase IIb clinical trial of ATX101, aimed at alleviating post-surgical pain in patients undergoing total knee replacement surgery.

This trial is a key step towards a potential new drug application (NDA) for ATX101.

The upcoming three-arm, randomised, controlled Phase IIb registration trial will enrol 200 participants at various US sites.

It will compare ATX101 1,500mg with a placebo and an active comparator, bupivacaine.

The area under the curve (AUC) of pain intensity over several weeks will be the primary endpoint of the trial.

A decline in the use of opioids, opioid-related side effects, and improvement in physical function will comprise secondary endpoints.

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The study will also gather data on additional functional and health economics outcomes, which will be pivotal for a global Phase III registration study intended to back an NDA submission.

The decision to proceed with the Phase IIb trial follows positive results from Allay’s recently concluded dose-ranging study, which enrolled 112 participants before an early termination due to favourable interim findings.

This data indicated that ATX101 provided sustained and clinically significant pain relief for up to four weeks post-surgery, outperforming the standard of care, bupivacaine.

Moreover, ATX101 treatment was associated with a reduction in opioid usage, fewer opioid-related side effects, and notable improvements in functional activities for up to 60 days post-operation.

Allay Therapeutics CEO Adam Gridley said: “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.

“The encouraging data from our recently completed Phase IIb 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.”