Trials Test Osteoarthritis Treatment

Ampio Pharmaceuticals, Inc., a development stage biopharmaceutical company in Greenwood Village, Colorado, is enrolling patients with severe osteoarthritis (OA) of the knee in Phase I and Phase II clinical trials. The Phase I trial will evaluate safety and pain reduction as a result of injections of Ampion. Phase II will evaluate efficacy and cartilage formation.

Osteoarthritis, which affects over 27 million people in the United States, is the most common form of arthritis. It is a progressive disorder of the joints involving degradation of the intra-articular cartilage, joint lining, ligaments, and bone. Osteoarthritis results in inflammation of the soft tissue and bony structures of the joint, which worsens over time and leads to progressive thinning of articular cartilage. The chance of developing osteoarthritis of the knee over a lifetime is approximately 46%.

Mike Macaluso, CEO of Ampio, explained, “This study is different from our prior OA clinical trials that were focused on obtaining a Biologics License from the FDA. Those trials were focused primarily on pain reduction using the WOMAC A scale. The current study will explore the possibility of additional clinical benefits including regeneration of cartilage.”

Macaluso added, “We have come to consider that Ampion may provide more clinical benefit than reduction of pain and this multiple injections study is designed to explore that possibility.”

The study will last for 52 weeks. In Phase I all patients will receive a dose of Ampion and no placebo will be used. In Phase II the patients will be randomized and half will receive a saline solution. Investigators will conduct high resolution MRI analysis by a radiologist expert in quantifying cartilage formation. The study will require MRI’s at baseline, at week 12, at week 24, and at week 52.