Enrollment has been completed for the AmpionTM Phase I US based clinical trial for IV treatment of COVID-19 patients requiring supplemental oxygen.
The final results from the 5-day treatment will be reported when the Safety Monitoring Committee (“SMC”) and the Principal Investigator complete their evaluations which we expect should occur within the next week.
The current Ampion Phase III clinical trial (“AP-013”) of an intra-articular injection of Ampion for treatment of severe OAK, was paused in April 2020 due to significant logistical issues associated with the COVID-19 pandemic.
Recently, the FDA has provided guidance specifically designed to assist the pharmaceutical industry with viable options for evaluating data from clinical trials which were adversely impacted by the pandemic.
In order to remain in compliance with such guidance, we will continue to remain blinded to the trial results achieved prior to pausing the trial, however, we are confident there will be sufficient objective information to support the submission of our proposal to the FDA. Our plan is to have this proposal completed and sent to the FDA early in the 4th quarter 2020.
Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options.
Ampio’s lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032 and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act (“BPCIA”).
Source: Company Press Release