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...
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