Currently, AYX1 is being developed for reduction of acute post-surgical pain and prevention of the transition to persistent or chronic pain with a single administration at the time of surgery.
With ADYX003, the company is building upon the results of the ADYX002 Phase II proof-of-concept study that was completed in late 2013.
Adynxx chief medical officer Dr Donald Manning said: "Given the lack of effective therapies for treating movement-evoked pain following surgery, this study was designed to optimize the therapeutic effect of AYX1 across a wide range of movement-evoked pain and range-of-motion assessments.
"Due to its unique mechanism of action, we believe AYX1 has the potential to transform the treatment of post-surgical pain, especially for surgeries with a high incidence of pain with movement and during rehabilitation such as total knee replacement."
A total of 120 patients were enrolled in the placebo-controlled ADYX003 trial, which is designed to 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 trial follows 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.