Ampio Receives feedback from the FDA on Ampio's Proposed Modifications to the special protocol assessment for Ampion treatment of severe Osteoarthritis of the knee
ENGLEWOOD, Colo., Dec. 29, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc.. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, announced today it has received guidance from the U.S Food & Drug Administration ("FDA") regarding the impact of COVID-19 on its Phase III clinical trial for osteoarthritis of the knee ("OAK").
The COVID-19 health emergency has impacted clinical trials, with over 1,000 studies suspended as a result of the pandemic, including the Phase III clinical trial ("AP-013") for the intra-articular injection of Ampion for treatment of severe OAK. The AP-013 study is being conducted under a Special Protocol Assessment ("SPA") which provides a documented framework for communication and gaining agreement with the FDA to support a commercial Biologics Licensing Application ("BLA").
In their feedback, the FDA agrees that OAK is a highly prevalent condition that affects millions of patients in the United States. In addition, the FDA provided practical guidance for the AP-013 study to navigate the pandemic, and to complete the study without re-running the trial. The FDA options give us the opportunity to provide additional evidence to support the use of existing data and/or add more patients to the trial. Ampio is thankful for this flexibility, is considering all options and is working to find a solution that will allow us to proceed despite COVID-19 and will present our analysis and proposal to the FDA as soon as possible.
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SOURCE Ampio Pharmaceuticals, Inc.
Company Codes: AMEX:AMPE