Friday December 15, 2017 0 comments
ENGLEWOOD -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) reported that the Phase 3 clinical trial of Ampion™ met its primary endpoint with 71% of Ampion treated patients meeting the OMERACT-OARSI responder criteria, which exceeds the physician reported threshold of 30% for a meaningful treatment in severe osteoarthritis of the knee (p < 0.001).
Responders experienced -- on average -- a 53% decrease in pain as measured by WOMAC A and a 50% improvement in function as measured by WOMAC C and a 45% improvement in quality of life as measured by Patient Global Assessment (PGA).
In the secondary endpoints, Ampio said Ampion treated patients achieved statistical significance in a composite endpoint of pain and function from baseline in both categories at 12 weeks (p < 0.001), which was supported by an increase in quality of life as measured by patient global assessment (PGA) (p < 0.001).
When treated with Ampion (n=144), patients experienced significant improvement in a composite endpoint of pain and function compared to all KL 4 saline-treated patients (n=206) in Ampion phase 3 clinical trials (p < 0.001).
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), the company said.
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 said.
Ampio said it 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.
"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," said Michael Macaluso, Ampio’s chair and CEO.
"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."