Adynxx announced completion of enrollment 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. Food and Drug Administration (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.
"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 enrollment 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," said Rick Orr, Chief Executive Officer of Adynxx. "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."