Adynxx begins Phase II trial of AYX1 for prevention of post-surgical pain

The company is focused on developing first-in-class platform of therapeutics to address pain at its molecular roots.

With ADYX-003, the company will build on the results of the recently completed ADYX-002 Phase II proof-of-concept study.

The 120-patient, placebo-controlled trial will assess the safety and efficacy of two dose-volume levels of a single administration of AYX1 given prior to unilateral total knee replacement to reduce acute pain with movement and to prevent the transition to persistent pain.

The trial will follow patients for 42 days with a primary endpoint of pain with walking, while secondary endpoints include pain at rest, pain with knee range of motion, opioid consumption and extent of functional recovery.

Adynxx chief medical officer Donald Manning said in the ADYX-002 proof-of-concept study, AYX1 was well-tolerated and demonstrated a consistent treatment effect across a spectrum of pre-defined movement-evoked pain and range-of-motion assessments.

"Further, this first efficacy study was very informative regarding the dose-volume relationship that drives the AYX1 treatment effect at its site of action," Manning said.

"The current ADYX-003 study is designed to leverage these first Phase 2 data to further enhance the scope and magnitude of the AYX1 therapeutic effect."

Adynxx founder and chief scientific officer Julien Mamet said the clinical results to date support the company’s approach to the treatment of pain and it is committed to advancing the development of AYX1 as rapidly as possible.

"Given the lack of effective treatment options for movement-evoked pain after surgery, we believe AYX1 has the potential to transform the therapeutic paradigm by preventing pain for the millions of patients who undergo surgery every year," Mamet said.