Benzinga | Aug 19, 2020 08:04AM EDT

Ampio Provides Update On COVID-19 Clinical Trial Activities

ENGLEWOOD, Colo., Aug. 19, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE),a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, provides updates regarding the following clinical trials:

* Ampion Phase I clinical trial for intravenous ("IV") treatment of COVID-19 patients: The initial safety assessments 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 AmpionTMtreatment for COVID-19 patients requiring supplemental oxygen. The results were reviewed by an independentSafety Monitoring Committee, comprised of four physicians, who found Ampion to be safe and well-tolerated,and who authorized the trial to moveto completion. Additional details of the trial can be found on clinicaltrials.gov (NCT04456452).

* Ampion IND application for inhalation treatment of COVID-19 patients: The FDA requestedcomprehensive tests on the safety of nebulized Ampionat various doses. Theresults 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 beingreviewed by the FDA. The addition of this safety datais expected tocomplete our IND application.

About Ampio Pharmaceuticals

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").