Ampio Pharmaceuticals, Inc.'s knee osteoarthritis injection Ampion met its primary goal in a phase 3 trial with 71% of patients reporting improvement in pain, function and quality of life.
Osteoarthritis is an incurable and progressive disorder of the joints involving degradation of the intra-articular cartilage, joint lining, ligaments and bone.
The patient response in the trial exceeds the physician reported threshold of 30% for a meaningful treatment in severe osteoarthritis of the knee.
On average, patients saw a 53% decrease in pain, 50% improvement in function and a 45% improvement in quality of life.
If approved, Ampion would be the first intra-articular injection to treat osteoarthritis of the knee. Ampion is also a non-opioid treatment.
The company is preparing to submit a biologics license application to the U.S. Food and Drug Administration.