Positive phase III data analysis for Ampion targeting severe osteoarthritis of the knee,- Ampio
Ampio Pharmaceuticals, Inc. announced positive data from the modified Intent-to-Treat (mITT) population in the Company’s AP-013 study, a Phase III clinical trial of the company’s lead candidate, Ampion, in patients suffering from severe osteoarthritis of the knee (OAK).
The AP-013 study was designed to confirm the efficacy observed in the first pivotal trial, AP-003-A, and was powered to detect treatment differences between Ampion and saline control. The trial required a larger number of patients to evaluate improvements in function, than it required to evaluate improvements in pain alone. The AP-013 study was initiated in June 2019 and was ongoing when the COVID-19 outbreak occurred, which resulted in a large amount of missing data due to the pandemic.
“As a result of the large amounts of missing data, our analyses of the AP-013 data started with applying FDA’s recommendation to conduct a sensitivity analysis to determine if there was an impact of COVID-19 on the study, which we outlined and documented in a study plan prior to unblinding the data,” said Holli Cherevka, Ampio’s President and Chief Operating Officer. “This sensitivity analysis found a statistically significant impact from COVID-19, and as specified in our study plan, we have proposed a mITT population to assess efficacy. In this mITT population (n = 618), which retained more than 85% power to evaluate improvements in pain, Ampion demonstrated a statistically significant reduction in pain (p=0.042) and trended favorably toward improvement in function versus saline control. Further, the results in the Per Protocol efficacy population (n = 580), included in the original AP-013 statistical analysis plan, support these observations with a statistically significant reduction in pain (p = 0.020) and a statistically significant improvement in function (p = 0.027) versus saline control.”
Mike Martino, Ampio’s Chief Executive Officer and Chairman added, “We believe that the AP-013 data confirms the results from AP-003-A and supports the safety and efficacy of Ampion for the treatment of pain from severe OAK. Earlier this year we submitted a Type C meeting request to FDA. FDA acknowledged our request and confirmed they will provide written responses to our questions as the next step. To support our position and inform FDA’s response, we recently submitted a detailed briefing package. I believe we are on track to provide clarity on AP-013 by the end of the first half of this year, as previously guided.”.
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