Ampion fails to meet endpoint in Phase III STRIDE study for Osteoarthritis:Knee- Ampio Pharma

Ampio Pharmaceuticals has announced that the multiple injection Phase III STRIDE study AP008 using Ampion (aspartyl-alanyl diketopiperazine) for pain due to osteoarthritis (OA) of the knee, did not reach its primary endpoint against the saline control even though there was a statistically significant reduction in pain compared to baseline for patients receiving Ampion (WOMAC A: p < 0.001). This pain reduction with Ampion was consistent across all sites and with previously reported studies (SPRING and STRUT). The data shows Ampion is safe and well tolerated. The company will meet with the FDA to discuss the clinical findings as soon as practical.

Comment: Ampion is the most advanced intra-articular injection in development for Osteoarthritis of the knee, but Flexion Therapeutics is competing and has reported topline data for its locally-injected, sustained release steroid FX 006. Flexion reports one of the three FX 006 doses tested in the study gave patients statistically significant and clinically meaningful pain relief versus an immediate-release steroid injection.