Ampio Pharmaceuticals Updates On COVID-19 Clinical Trial Activities - Quick Facts

(RTTNews) - Biopharmaceutical company Ampio Pharmaceuticals, Inc. (AMPE) on Wednesday provided an update regarding the COVID-19 clinical trial activities.

The initial safety assessments in the Ampion Phase I clinical trial for intravenous (IV) treatment of COVID-19 patients are complete and the trial is cleared to enroll the remaining patients for the Phase I US-based clinical trial evaluating a 5-day IV AmpionTM treatment for COVID-19 patients requiring supplemental oxygen. Ampion was found to be safe and well-tolerated after review by an independent Safety Monitoring Committee, comprised of four physicians.

Further, in the Ampion IND application for inhalation treatment of COVID-19 patients, the FDA requested comprehensive tests on the safety of nebulized Ampion at various doses. The results of these tests have been reviewed by independent toxicologists who found no evidence of toxicity in preclinical trials, even at extreme doses, and this extensive data has been submitted to the FDA.

A clinical trial protocol for treating patients who have respiratory distress due to COVID-19 with nebulized Ampion has already been submitted and is being reviewed by the FDA. The addition of this safety data is expected to complete our IND application.