Phase 2 dose-ranging study of AYX1 for prevention of post-surgical pain

Adynxx, developer of a first-in-class platform of therapeutics to address pain at its molecular roots, announced today that the first patient was dosed in ADYX-003, a Phase 2 dose-ranging study of AYX1, an investigational drug candidate for the prevention of post-surgical pain. With ADYX-003, Adynxx will build on the results of the recently completed ADYX-002 Phase 2 proof-of-concept study.

The 120-patient, placebo-controlled study will evaluate 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 study will follow patients for 42 days with a primary endpoint of pain with walking. Secondary endpoints include pain at rest, pain with knee range of motion, opioid consumption and extent of functional recovery. Further details of the study can be found at www.clinicaltrials.gov.

"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," said Donald Manning, M.D., Ph.D., chief medical officer of Adynxx. "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."

"The clinical results to date support Adynxx's approach to the treatment of pain and we are committed to advancing the development of AYX1 as rapidly as possible," added Julien Mamet, Ph.D., founder and chief scientific officer of Adynxx. "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."