Ampio Pharmaceuticals Inc. recently announced the results from its PIVOT clinical trials to access the efficacy and safety of Ampion intra-articular injection among patients who have pain from osteoarthritis (OA) in their knees.
This double-blind saline-controlled Phase III clinical trial enrolled a total of 480 patients, with 20 participating sites throughout the U.S.
As a primary endpoint, the study sought to change the WOMAC A pain by the 12th week of the treatment over saline. Further analyses detailed Patient Global Assessment (PGA), adverse events (AEs), and responder status defined as 20 percent improvement in pain at week 12.
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) assesses pain, stiffness, and physical function in patients with knee osteoarthritis.
Although the treatment was well tolerated, the study failed to meet its end point.
Ampio stated that the study results will soon be presented to the U.S. Food and Drug Administration (FDA).
"Ampio has the opportunity to provide treatment where there is a clear unmet medical need,” Michael Macaluso, Ampio's CEO, said. “Even though we did not meet the primary end point in the PIVOT study, we are pleased with the consistent effect Ampion demonstrated in all of our clinical trials. Ampio is requesting a meeting with the FDA to present our data in support of Ampion."