Ampio gets FDA feedback on proposed modifications to special protocol assessment for Ampion

Wednesday December 30, 2020 0 comments Tags: Englewood, Ampio Pharmaceuticals, Ampion, COVID-19, FDA

ENGLEWOOD -- Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) today announced it received guidance from the U.S Food & Drug Administration regarding the impact of COVID-19 on its Phase III clinical trial for osteoarthritis of the knee ("OAK").Ampio_logoUSE 

The COVID-19 health emergency has impacted clinical trials, with more than 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.

Ampio said the AP-013 study is being conducted under a Special Protocol Assessment that provides a documented framework for communication and gaining agreement with the FDA to support a commercial Biologics Licensing Application.

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 Apio the opportunity to provide additional evidence to support the use of existing data and/or add more patients to the trial.

Ampio said it is thankful for this flexibility, is considering all options and is working to find a solution that will allow the company to proceed despite COVID-19 and will present Ampio’s analysis and proposal to the FDA as soon as possible.

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