5:31 AM
Apr 12, 2018
 |  BC Extra  |  Clinical News

Adynxx planning Phase III for pain candidate despite Phase II miss

Adynxx Inc. (San Francisco, Calif.) said that although brivoligide (AYX1) missed the primary endpoint in the Phase II ADYX-004 trial to treat postsurgical pain, the company still sees a path to Phase III based on subgroup data from the trial. Adynxx plans to start a Phase III trial of brivoligide in early 2019 to treat postsurgical pain in patients with high Pain Catastrophizing Scale (PCS) scores. The candidate is an early growth response 1 (EGR1) inhibitor.

On the primary endpoint in the total population, brivoligide failed to significantly reduce mean pain with walking from days 7-28 after surgery vs. placebo. Adynxx said it is not disclosing detailed data or p-values at this time.

However, Adynxx said brivoligide led to a "sustained and clinically meaningful" reduction in pain and opioid use in a prespecified subgroup of patients with baseline PCS scores of 20 points or higher.

PCS is a 13-item clinical tool used to assess the three domains of catastrophizing pain -- rumination, helplessness and magnification. According to the company, patients with a score of 16 points or higher on the PCS are more likely to experience inadequate pain relief following surgery and represent 25-35% of all patients undergoing surgery.

In the subgroup, brivoligide reduced the time to achieve mild pain by 26 days (15 vs. 41 days) and reduced opioid use by 37% vs. placebo. Furthermore, brivoligide reduced pain at rest by 30% and pain with walking by 25% from days 7-28 vs. placebo in the subgroup.

The trial enrolled a total of 210 patients undergoing unilateral total knee arthroplasty to receive a single intrathecal preoperative dose of 660 mg brivoligide or placebo. Patients also received standard perioperative pain management.

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