Top Line Results from AP-013 Phase III by Ampio Pharmaceuticals

Ampio Pharmaceuticals, a biopharmaceutical company focused on the advancement of immunology-based therapies for common inflammatory conditions, announced today top-line results from AP-013, a randomized, saline-controlled, double-blind Phase III clinical study evaluating the efficacy of an intra-articular (IA) injection of AmpionTM in adults with severe osteoarthritis pain (OAK). Ampion showed a statistically significant reduction in pain and improvement in function in severe OAK patients after 12 weeks in the research.

The AP-013 trial was the second of two Phase III pivotal trials necessary to prove the efficacy of an IA injection of Ampion for treating patients with severe OAK. After adopting AP-003-A as the first of two needed Phase III pivotal studies, the FDA acknowledged that Ampion had effectiveness in OAK patients. The FDA has designated severe OAK as an unmet medical need. Presently, there are no FDA-approved medications for treating the pain associated with tough OAK, which Ampion is designed for.

The FDA suggested that the company identify subject information impacted by the COVID-19 pandemic during the AP-013 clinical investigation and conduct a sensitivity analysis to discover potential biases linked to the pandemic as a result of the COVID-19 pandemic. The company followed the FDA’s instructions, did top-line research, and ran the FDA-recommended sensitivity study. The data shows that the pandemic had a statistically significant impact.

Furthermore, a separate statistical analysis of data from 725 patients who the company believed were not affected by the pandemic revealed a statistically significant reduction in pain and improvement in function with Ampion treatment compared to saline control at 12 weeks versus a critical p-value of 0.05.