Ampio Pharma Reports Positive Results From SPRING Study Extension Of Ampion

(RTTNews) - Ampio Pharmaceuticals, Inc. (AMPE) announced positive results from the eight week extension of the twelve week SPRING study of Ampion for the treatment of osteoarthritis of the knee.

In the 329 patient Spring Study, both the efficacy and safety of the 4 mL and 10 mL doses were equivalent. Both doses were independently statistically significant, therefore Ampio selected 4 mL as the optimal dose for the extended study and followed the 97 patients who were administered either 4 mL Ampion or saline vehicle control for an additional 8 weeks.

At week twenty, 50% of patients in the Kellgren-Lawrence grades of 3 and 4 (severe osteoarthritis) had improvement of 40% or more in the WOMAC A pain scale compared to 25% in the vehicle control group. In the same grade 3 & 4 patients, there was a statistically significant improvement in pain (WOMAC A) compared to the vehicle control both at week 20 and over the whole period of 20 weeks. Also in these same grade 3 & 4 patients, there was a statistically significant improvement in function (WOMAC C) compared to vehicle control both at week 20 and over the whole period of 20 weeks.

Ampio Pharma said, during its October 29th pre-BLA meeting, the company provided complete clinical data set to the FDA and discussed possible courses of action leading to the submission of a BLA. Ampio Pharma awaits the FDA's guidance.