Investors love biotech stocks for the lottery ticket-like returns they can offer if a company strikes medical gold. Case in point: Ampio Pharmaceuticals Inc (NYSE:AMPE), whose shares are jumping nearly 50% in Thursday trading session.
The reason? The biopharmaceutical company reported that its knee osteoarthritis drug Ampion met its primary endpoint in Phase 3 clinical trial. Specifically, 71% of Ampion treated patients met OMERACT-OARSI responder criteria, which exceeds the physician reported threshold of 30% for a meaningful treatment in severe osteoarthritis of the knee.
Ampio Chairman and CEO Michael Macaluso commented, “We are very pleased with the positive Phase 3 data as we believe that Ampion™ will address an unmet medical need, providing severely diseased patients a non-opioid option that not only reduces pain, but also improves function and quality of life in a meaningful way […] We are hopeful that Ampion™ will serve as a safe and effective treatment for an incurable, progressive disease that afflicts 21 million people in the U.S. and over 200 million people worldwide who suffer from osteoarthritis. We look forward to working closely with the U.S. Food and Drug Administration (FDA) as we prepare to submit our Biologics License Application (BLA) for Ampion.”
If approved, Ampion would be the first intra-articular injection to treat the signs and symptoms of patients with severe osteoarthritis of the knee (Kellgren-Lawrence x-ray grade 4). In order to support a label for signs and symptoms, Ampion was asked to demonstrate clinical efficacy in a composite response of pain, function and be supported by quality of life.
Ampion was well tolerated with treatment-emergent adverse events (TEAEs) comparable to those of placebo in all single-injection studies of Ampion. There were no drug-related serious TEAEs associated with the Ampion arm. The safety and tolerability profile of Ampion is consistent with previous studies. To date, Ampion has been given to over 900 patients with no reported drug-related serious TEAEs.
Ampio plans to present a more detailed analysis of the Phase 3 and pooled data at an upcoming scientific meeting as well as submission for publication.
In this multi-center, randomized study of 144 KL4 patients with severe OAK of the knee, patients received either a single 4mL intra-articular injection of Ampion or placebo at a ratio of 6:1. The primary endpoint of responder analysis using OMERACT-OARSI was evaluated at 12-weeks following a single injection.
Ampio Pharmaceuticals is a biopharmaceutical company, that engages in the development of therapies to treat prevalent inflammatory conditions. Its product pipeline includes new uses for approved drugs and new molecular entities for important therapeutic areas, including metabolic disease, eye disease, kidney disease, inflammation, sexual dysfunction and CNS disease. The company was founded by David Bar-Or in April 2010 and is headquartered in Greenwood Village, CO.