US-based biotechnology firm Adynxx has completed patient enrolment in a Phase II trial (ADYX-004) of its lead product candidate, brivoligide (AYX1), for reducing acute pain and preventing chronic pain following total knee replacement surgery.
The product inhibits the activity of EGR1, a transcription factor that plays a major role in establishing and maintaining pain following injury or trauma.
Brivoligide has also received fast-track designation from the US Food and Drug Administration (FDA) for the prevention of chronic pain.
A total of 200 people have been enrolled in the nine-centre, randomised, double-blind, placebo-controlled trial, which is designed to evaluate the safety and efficacy of a single pre-operative dose of brivoligide for the prevention of pain following surgery.
During the trial, subjects will be followed for 90 days after unilateral total knee replacement surgery, with a primary endpoint of pain during walking from days seven to 28 compared to placebo.
The trial’s secondary endpoints include the percentage of subjects with moderate-to-severe pain at 90 days following surgery, pain at rest, and time to achieve adequate pain relief.
Adynxx chief executive officer Rick Orr said: “Given the International Association for the Study of Pain has declared 2017 the Global Year Against Pain After Surgery, we are pleased with the rapid enrolment in this study and look forward to further demonstrating brivoligide can speed recovery from post-surgical pain and prevent that pain from becoming chronic with a single administration at the time of surgery.
“Additionally, with the opioid epidemic here in the United States and abroad, we are committed to advancing brivoligide as quickly as possible as a non-opioid treatment option for the benefit of millions of patients undergoing surgery every year.”
According to the company, results from the trial are expected to be reported in the first quarter of next year.
Image: Knee replacement. Photo: courtesy of BruceBlaus via Wikipedia.