Ampio Pharma Completes Enrollment And Dosing For Ampion - Quick Facts

(RTTNews) - Ampio Pharmaceuticals, Inc. (AMPE) announced it has completed enrollment and dosing of 500 patient in the pivotal trial of Ampion for the treatment of acute osteoarthritis of-the-knee. The phase III trial is a randomized, placebo controlled, double-blind study in which 500 patients with osteoarthritis of the knee were randomized to 4 ml intra-articular injection of Ampion, or a 4 ml saline vehicle control. Similar to the initial pivotal trial (SPRING study) the primary end point is at 12 weeks, with a follow up evaluation at 20 weeks.

Ampio CEO Michael Macaluso said: "The company is on track to complete this final Ampion clinical trial within the timeline previously announced and we expect to file the BLA later this year. The manufacturing facility is expected to begin production of test batches of Ampion early this summer."