Ampio Pharma Reports Positive Results From SPRING Study Of Ampion - Quick Facts

(RTTNews) - Ampio Pharmaceuticals Inc. (AMPE) announced positive results from the SPRING study of Ampion for the treatment of osteoarthritis of the knee. In the study, patients achieved a clinically meaningful reduction in pain.

Patients were randomized to receive one of two doses (4 mL or 10 mL) of Ampion or corresponding saline control via intra-articular injection. The primary study objective was to evaluate the relative efficacy of Ampion 4 mL versus Ampion 10 mL. The primary endpoint was mean change in pain from baseline for Ampion compared to the same volume of saline. Secondary endpoints included evaluating safety and quality of life, as well as, stiffness and function.

Ampion dose cohorts experienced statistically significant reductions in pain compared to control. There were no significant differences between the efficacy of the two Ampion doses. The company said selection of the optimal dose for the second Phase 3 trial will be decided in consultation with the FDA.