Clinical Trials Arena

Allay’s ATX101 offers post-surgical pain relief in Phase IIB trial

In the trial, ATX101 was well tolerated with its safety profile generally comparable to that of bupivacaine.

Allay Therapeutics has reported data from a Phase IIB clinical trial of its lead investigational product, ATX101, for post-surgical pain relief.

The trial, involving 13 sites across Australia, Canada, and the UK, compared ATX101 to the standard of care, bupivacaine, an approved non-opioid analgesic that typically provides only one day of pain relief.

ATX101 is a new formulation comprising a bioresorbable polymer and bupivacaine.

The study data indicated that ATX101 could offer sustained relief for up to four weeks following total knee arthroplasty, surpassing the current standard of care.

It demonstrated a rapid onset of action and maintained efficacy comparable to bupivacaine over the initial 24 hours.

Patients treated with ATX101 experienced clinically meaningful reductions in pain for up to 30 days post-surgery.

Notably, there was a significant decline in opioid consumption over four weeks compared to those receiving bupivacaine.

ATX101 was well tolerated with its safety profile generally comparable to that of bupivacaine. Most treatment-emergent adverse events reported in the trial were mild or moderate in severity.

These findings will inform the design of a Phase IIb study anticipated to commence this year.

Based on this study’s success, the company plans to submit a new drug application with the US Food and Drug Administration for the asset in this indication.

Allay Therapeutics chief medical officer David Hewitt said: “These results support the potential of ATX101’s ability to transform the post-surgical pain management paradigm by delivering non-opioid-based, ultra-sustained pain relief for weeks following knee replacement surgery.

“Its simple administration has the potential to replace complex and costly existing protocols while providing rapid and extended pain relief over weeks, thereby reducing the burden of these surgeries for patients, physicians and payors alike.

“With a growing body of supportive clinical data for ATX101 in TKA, we are highly encouraged regarding the other ultra-sustained product candidates in our portfolio.”