Results from the PIVOT phase III trial of Ampion show safety and efficacy in osteoarthritis of the knee- Ampio Pharma

Ampio Pharmaceuticals announced the results of the Ampion PIVOT clinical trial of Ampion intra-articular injection in patients with pain due to osteoarthritis (OA) of the knee, as well as a comprehensive analysis that integrates trial data from three single injection studies that will be presented to the FDA. The PIVOT trial, which included 480 patients, was a double-blind saline-controlled phase III clinical trial performed in 20 sites across the US to examine the safety and efficacy of Ampion in patients with pain due to 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. Ampion was demonstrated to be safe and well-tolerated with no drug-related serious AEs and an overall AE rate that was similar in the Ampion and saline groups. OA severity was defined by the Kellgren Lawrence scale (KL). Ampion improved WOMAC A pain significantly over baseline in all KL grades (KL 2: 52%, KL 3: 36%, and KL 4: 33% reductions in pain) but the primary end point was not met. The Company observed the largest differentiation between Ampion and saline in the most severe OA patients (KL 4), where no available non-surgical therapy exists. KL 4 patients have been historically excluded from knee OA trials because of the advanced stage of their condition. Safety data will be presented to support the clinical benefit, as there were no drug-related safety issues observed.

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.