Ampio's Phase III trial of osteoarthritis therapy fails to meet primary endpoint

US pharma company Ampio Pharmaceuticals’ (Nasdaq: AMPE) Phase III study of Ampion did not reach its primary endpoint. The news sent the firm's shares crashing 65.8% to $2.69 in after-hours trading on Monday.

Although there was a statistically-significant reduction in pain compared to baseline for patients receiving Ampion, the primary endpoint of saline control was not met. The study found Ampion to be safe and well-tolerated.

Ampion is a low-molecular weight filtrate of a Food and Drug Administration-approved biologic, launched by Ampio Pharmaceuticals to treat pain due to osteoarthritis of the knee. Each patient received three 4ml intra-articular injections of Ampion or saline placebo, one at baseline, the second at two weeks and the third at four weeks. Saline is known to be a partial therapeutic in osteoarthritis, rather than a true placebo, but has also been the control used in all published trials in this indication.