Ampion™ reduces severe knee osteoarthritis pain in 12 weeks
Ampion significantly reduced pain and improved function in severe osteoarthritis of the knee (OAK) in 12 weeks, shows Phase III study.
Ampio have announced top-line results from AP-013, a randomised, saline-controlled, double-blind Phase III clinical study evaluating the efficacy of an intra-articular (IA) injection of Ampion™ in adults with pain due to severe osteoarthritis of the knee (OAK). In the study, Ampion demonstrated a statistically significant reduction in pain and improvement in function at 12 weeks in severe OAK patients.
The AP-013 study was designed to confirm the efficacy of an IA injection of Ampion for the treatment of patients with severe OAK and the second of two required Phase III pivotal trials. The study used the WOMAC® A (Pain Subscale) index/scoring system as the measurement of pain and WOMAC® C (Function Subscale) index/scoring system as the measurement of function and the statistical analysis for computing the top-line results utilised the same methodology defined in the first pivotal study (AP-003-A).
Notably, resulting data demonstrated a statistically significant impact from the pandemic (p<0.001). However, a separate statistical analysis of data from the 725 patients that Ampio believed not to have been impacted by the pandemic demonstrated a statistically significant reduction in pain (p=0.0260) and improvement in function (p=0.0073), versus a critical p-value of 0.05, at 12 weeks with Ampion treatment compared to saline control.
The US Food and Drug Administration (FDA) has identified severe OAK as an unmet medical need, and there are currently no FDA-approved drugs for the indication of pain from severe OAK, for which Ampion is indicated.
“We are deeply grateful to the patients, investigators and others who have participated in this study,” commented Mike Macaluso, President & Chief Executive Officer of Ampio. “We will complete the analysis of the AP-013 study and present all data to the FDA with the goal of filing a Biologics License Application (BLA) for Ampion.“