Ampion: Phase III data

The double-blind, U.S. Phase III STRIDE (AP008) trial in about 320 patients with moderate to severe OA of the knee showed that 3 intra-articular injections of 4 mL Ampion given 2 weeks apart missed the primary endpoint of improving WOMAC 3.1 score from baseline to week 20 vs. saline. Ampion did significantly improve WOMAC-A pain subscale score at week 20 compared to baseline (p<0.001). Ampio said the saline arm in STRIDE “varied well out of a normal range” compared to previous trials of Ampion and to published results for other OA drugs. In STRIDE, the percent change in WOMAC-A scores ranged from 12-60% from site to site in the saline arm, which Ampio said is more than twice the range seen in previous trials of Ampion. The company said that in larger trials, the historical response to saline has been reported to be 30-35%. Ampion was well tolerated. ...