- Ampio Pharmaceuticals Inc (NYSE:AMPE) received written responses from the FDA pursuant to a Type C meeting request regarding the AP-013 Phase 3 trial results.
- In March, Ampio announced data from the modified Intent-To-Treat (mITT) population (n=618) in the AP-013 study of Ampion in severe osteoarthritis of the knee (OAK).
- Ampion demonstrated a statistically significant reduction in pain (p=0.042) and trended favorably toward improving function versus saline control.
- FDA disagreed with the proposed change from the ITT population to the mITT population that mITT is a substantive and material change to the Protocol and Statistical Analysis Plan that is not under the Special Protocol Assessment agreement.
- It also said that despite the COVID-related impact on patients and trial centers, the Company should have sought FDA's agreement on these changes before analyzing and unblinding the data.
- FDA further stated that it did not agree that AP-013 could serve as a second pivotal trial for Ampion based on the change in the analysis population and pain only instead of the original prespecified co-primary endpoints.
- "At this point, I believe the best path forward for Ampio and Ampion is likely conducting a new Phase 3 trial," said Mike Martino, CEO & Chairman.
- Price Action: AMPE shares closed 36.8% lower at $0.22 during after-hours trading on Wednesday.
