Ampio Updates On Phase III STEP Study Of Ampion For Osteoarthritis Of Knee

(RTTNews) - Ampio Pharmaceuticals, Inc. (AMPE) announced an update on the phase III, multicenter, double-blind STEP study of Ampion for osteoarthritis of the knee.

The STEP study enrolled 538 patients, 269 patients received Ampion and 269 patients received saline vehicle control. There were two primary endpoints such as efficacy in reducing pain and safety of Ampion. The WOMAC C Function subscore was examined as a secondary endpoint. Changes in pain and function from baseline between Ampion and saline treatment groups were analyzed using a mixed model, adjusted for baseline score. Safety was examined in the safety dataset while efficacy was analyzed in the per-protocol population, in which patients met all entry criteria and had no major protocol deviations. There were 475 patients included in the PP population.

The data review from the STEP study confirmed that 72% patients received study medication that had fallen below the product specification temperature range. The average length of exposure below this temperature range was 16.1 hours.

The firm plans to present safety data From the Australian phase I and Phase II studies as well as the SPRING, STEP and Multiple Injections studies for the BLA. Efficacy data for the BLA would be drawn from the SPRING and Multiple Injections Study. The company plans to submit the BLA before the end of the first quarter 2015.