Ampio Pharma Shares Fall As FDA Rejects Proposed Change In Knee Osteoarthritis Trial

Ampio Pharmaceuticals Inc 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.