Ampio Pharma tumbles as it faces FDA delay on osteoarthritis drug

Shares of Ampio Pharmaceuticals (NYSE American: AMPE) closed down 27% at $0.25 yesterday, as the US biopharma company announced the receipt of written responses from the US Food and Drug Administration regarding the AP-013 trial results, suggesting it will likely need to perform a further Phase III study.

As previously disclosed, the company submitted its Type C meeting request to gain clarity from the FDA regarding the acceptability of the proposed modified intent-to-treat (mITT) population as the primary analysis population for evaluating efficacy in the AP-013 trial, and the acceptability of AP-013 as a second pivotal trial to support a biologics license application (BLA) for Ampion, a pain treatment for osteoarthritis of the knee and other joints.

The FDA responded that it did not agree with the Ampio's proposed change from the ITT population to the mITT population for the primary endpoint analysis, that mITT is a substantive and material change to the Protocol and Statistical Analysis Plan that is not in accordance with the Special Protocol Assessment agreement, and that despite the COVID related impact on patients and trial centers, the company should have sought the FDA's agreement on these changes prior to analyzing and unblinding the data. The FDA further stated that it did not agree that AP-013 could serve as a second pivotal trial for Ampion based on both the change in the analysis population and the analysis of pain only instead of the original prespecified co-primary endpoints.