Ampio Pharma (AMPE) Announces Positive Top-line Phase 3 Results of AP-013 in Adult Patients Suffering from Severe Osteoarthritis of the Knee (OAK)

Ampio Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced 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 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 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. We plan 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.

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.

"We are deeply grateful to the patients, investigators and others who have participated in this study," shared Mike Macaluso, President & CEO of Ampio. "I am also very pleased with our current cash and liquidity runway, which we believe is sufficient to support our basic operations and expected incremental spend for current and ongoing clinical trials for approximately twelve months, while we continue regulatory and partnering discussions related to Ampion. We 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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