An independent special committee of the board of Ampio Pharmaceuticals (NYSE American:AMPE), with the assistance of independent legal counsel, is in the process of conducting an internal investigation that relates to, among other matters, Ampio’s AP-013 clinical trial and other clinical trials.
Last month, the FDA rejected the company’s data from AP-013 for evaluating efficacy as a second pivotal trial for Ampion, which is in development for the treatment of severe osteoarthritis.
“Management’s recent analyses also indicate no clinically meaningful treatment effect signals from the company’s three COVID-19 clinical trials, AP-017, AP-018, or AP-019,” the company said in a statement.
In addition, the board committee is overseeing a review of unauthorized use of Ampion by individuals not participating in clinical trials. Ampio said it has instituted safeguards to cease this practice and engaged independent outside counsel to conduct a thorough review, which is ongoing.
The Ampio board also has begun a process to consider strategic alternatives for Ampio and Ampion, which may include the continued development and advancement of Ampion, capital raising, licensing and other partnering opportunities, positioning the company for a strategic transaction or other alternatives.