Dive Brief:
- Inflammation-focused biopharma Ampio Pharmaceuticals Inc. on Thursday announced its serum-derived therapeutic Ampion succeeded in meeting the primary and secondary endpoints in its severe osteoarthritis-of-the-knee study. The company said it would discuss filing for approval with U.S. regulators.
- After a single injection into the knee, over 70% of the patients exceeded the threshold of "meaningful treatment." The people who responded had a 53% decrease in pain, a 50% improvement in function and a 45% improvement in quality of life. Further details will be presented at a scientific meeting.
- Ampio hopes Ampion, a low molecular weight fraction of human serum albumin, could be the first intra-articular injection to market to treat the signs and symptoms of severe osteoarthritis of the knee.
Dive Insight:
Osteoarthritis affects up to 27 million people in the U.S. — around 12% of the adult population. Almost half of people will develop osteoarthritis of the knee over a lifetime, and this is expected to increase as the population ages and as levels of obesity climb. This make for a potentially huge market that Ampio Pharmaceuticals Inc. is hoping to tap into.
"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," said company CEO Michael Macaluso.
Joint pain is often treated with non-steroidal anti-inflammatory drugs, and while these can be very effective, they can trigger serious side effects, such as gastrointestinal effects, bleeding, liver and kidney problems and high blood pressure. Opioids may also be used in patients who can't get relief with other drugs, but come with risks of addiction, diversion and deaths. Non-opioid, non-NSAID therapeutics such as Ampion could provide a safer and better-tolerated alternative
This news could signal a turnaround for Ampio. Two previous Phase 3 trials for Ampion failed, in 2015 and 2016, sending shares down by around 60% each time. The current study may be the break Ampio needs, but time will tell to see if the FDA agrees.