Ampio says Phase 3 clinical trial of Ampion met its primary endpoint
Ampio Pharmaceuticals (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 less than 0.001).
Osteoarthritis, commonly known as wear-and-tear arthritis, is a condition in which the natural cushioning between joints — cartilage — wears away. When this happens, the bones of the joints rub more closely against one another with less of the shock-absorbing benefits of cartilage. The rubbing results in pain, swelling, stiffness, decreased ability to move and, sometimes, the formation of bone spurs.
While it can occur even in young people, the chance of developing osteoarthritis rises after age 45. According to the Arthritis Foundation, more than 27 million people in the U.S. have osteoarthritis, with the knee being one of the most commonly affected areas. Women are more likely to have osteoarthritis than men.
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.
In the secondary endpoints, Ampion treated patients achieved statistical significance in a composite endpoint of pain and function from baseline in both categories at 12 weeks (p less than 0.001), which was supported by an increase in quality of life as measured by patient global assessment (p less than 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 less than 0.001).
Ampion was well tolerated with treatment-emergent adverse events 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.
AMPE closed at $1.75.
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