Biopharmaceutical company Ampio Pharmaceuticals Inc (nyse mkt:AMPE) stated on Tuesday that it has dosed 500 patient in the second pivotal trial of Ampion for the treatment of acute osteoarthritis of-the-knee (OAK) following enrollment.
According to the company’s chief regulatory officer, Dr Vaughan Clift, this phase III, final pivotal clinical trial is a randomised, placebo (vehicle) controlled, double-blind study in which 500 patients with osteoarthritis (OA) of the knee were randomised to 4 ml intra-articular injection of Ampion, or a 4 ml saline vehicle control.
The primary end point is at 12 weeks, with a follow up evaluation at 20 weeks and the clinical effects of treatment on OA pain will be evaluated during clinic visits at six, 12 and 20 weeks using WOMACR osteoarthritis index and Patient’s Global Assessment (PGA) of disease severity, Dr Clift stated.
The company is on track to complete this final Ampion clinical trial within the timeline and expects to file the BLA later this year. The manufacturing facility is expected to begin production of test batches of Ampion early this summer, CEO Michael Macaluso added.
Osteoarthritis is the most common form of arthritis, affecting over 27m people in the US. It is a progressive disorder of the joints involving degradation of the intra-articular cartilage, joint lining, ligaments and bone. The incidence of developing osteoarthritis of the knee or hip over a lifetime is approximately 46% and 25%, respectively.
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