Adynxx Inc. dosed the first patient in a placebo-controlled Phase 2 clinical study of its lead investigational drug candidate AYX1, designed to reduce acute post-surgical pain and prevent the transition to persistent or chronic pain with a single administration at the time of surgery. The study, which will enroll 90 patients, is designed to demonstrate the safety and efficacy of a single administration of AYX1 given prior to unilateral total knee arthroplasty (TKA) to reduce acute pain and prevent the transition to chronic pain. The study's primary endpoint includes pain with walking and secondary and exploratory endpoints include pain at rest, pain with knee range of motion, rate and extent of functional recovery, opioid consumption and safety assessments.

The study is expected to follow patients for 42 days. In addition, the company's additional therapeutic drugs in the AYX platform are currently under active preclinical development for the treatment of chronic lower back pain, intractable neuropathic and inflammatory pain syndromes.