Top-line results from AP 013 phase III trial of Ampion in adult patients with severe osteoarthritis of the knee.- Ampio Pharma
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 the two required Phase III pivotal trials. The FDA has acknowledged that Ampion has demonstrated efficacy in OAK patients after accepting AP-003-A as the first of two required Phase III pivotal studies. The 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.
As a result of the COVID-19 pandemic, the FDA recommended that the Company identify subject information that was impacted by the pandemic during the AP-013 clinical study and conduct a sensitivity analysis to detect potential biases related to the pandemic. The Company has followed FDA’s guidance, completed a top-line analysis, and performed the FDA-recommended sensitivity analysis. The resulting data demonstrates a statistically significant impact from the pandemic (p<0.001). in addition, a separate statistical analysis of data from the 725 patients that the company 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 company plasn to thoroughly analyze and consolidate all this study data with data from severe oak patients in previous single-injection clinical studies performed by the company and present it to the fda in support of a bla.></0.001).>
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 utilized the same methodology defined in the first pivotal study (AP-003-A). These results obtained are consistent with the results from severe OAK patients in prior OAK trials conducted by the Company and significantly expand the set of severe OAK patients treated with Ampion. The safety profile of Ampion remains strong, and no treatment-related serious adverse events were observed among the cohort of patients who received Ampion.
The company will complete the analysis of the AP-013 study and present all data to the FDA with the goal of filing a BLA for Ampion.
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