Ampio's Ampion misses endpoint in Phase III osteo pain trial

Ampio Pharmaceuticals (NYSE MKT: AMPE) today announced disappointing results of the Ampion PIVOT clinical trial as well as a comprehensive analysis that integrates trial data from three single injection studies that will be presented to the Food and Drug Administration.

The Phase III trial for Ampion, its osteoarthritis pain treatment, missed its primary endpoint, with the news sending the firm’s share price plunging 71.39% to $0.95. Ampion is a low-molecular weight filtrate of an FDA-approved biologic, developed by Ampio to treat pain due to osteoarthritis of the knee.

The PIVOT study, which included 480 patients, was a double-blind saline-controlled Phase III clinical trial performed in 20 sites across the USA to examine the safety and efficacy of Ampion intra-articular injection in patients with pain due to osteoarthritis (OA) of the knee. The primary endpoint was the change in WOMAC A pain at week 12 as compared to saline. Additional analyses included adverse events (AEs), Patient Global Assessment (PGA), and responder status defined as 20% improvement in pain at week 12.