Ampion fails to meet primary endpoint of STRIDE study in patients with knee OA

Ampio pharmaceuticals announced its injectable low-molecular-weight filtrate of an FDA-approved biologic, Ampion, failed to meet its primary endpoint in a phase 3 trial, despite a statistically significant reduction in pain compared with baseline.

During the STRIDE study, approximately 320 patients with osteoarthritis (OA) received either a 4-mL intra-articular injection of Ampion or a saline placebo at baseline, 2 weeks and 4 weeks. Unexpectedly positive results achieved within the placebo arm of patients were attributed to the fact that saline is “not a true placebo” because it has known therapeutic effects in OA, according to a company press release. The company stated that in previous trials, however, response rates to saline placebo have been 30% to 35%, not the range of 12% to 60% seen at varied sites in the STRIDE trial.

Ampio also reported 68% of the patients included in the study had severe disease compared with 38% and 23% of patients in prior studies, and that patients were also heavier than in previous trials.

The company intends to meet with the FDA to discuss the results and said it believes the prior studies should provide sufficient evidence of efficacy to meet market approval, according to the release.

Reference : www.ampiopharma.com.