Posted by Michael Wonder on 08 Oct 2017
Adynxx completes enrolment in ADYX-004, a Phase 2 study of brivoligide, lead compound for the treatment of post-surgical pain
4 October 2017 - ADYX-004 study to evaluate safety and efficacy of a single pre-operative dose of brivoligide for the prevention of pain following total knee replacement surgery.
Adynxx announced today completion of enrolment in a Phase 2 study of its lead product candidate, brivoligide (AYX1), for reducing acute pain and preventing chronic pain following surgery. Brivoligide inhibits the activity of EGR1, a transcription factor that plays a critical role in establishing and maintaining pain following injury or trauma. The U.S. FDA granted fast track designation to brivoligide for the prevention of chronic pain.
The 200-subject, nine-center, randomized, double-blind, placebo-controlled study follows subjects for 90 days after unilateral total knee replacement surgery, with a primary endpoint of pain with walking from day 7 to 28 compared to placebo. Secondary endpoints include the percentage of subjects with moderate to severe pain at 90 days following surgery (a measure representing the prevention of chronic pain), pain at rest, and time to achieve adequate pain relief. Data from the study are expected in the first quarter of 2018.
