Ampio Provides Update on COVID-19 Clinical Trial Activities

Ampio Pharmaceuticals, Inc., 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 AmpionTM treatment for COVID-19 patients requiring supplemental oxygen. The results were reviewed by an independent Safety Monitoring Committee, comprised of four physicians, who found Ampion to be safe and well-tolerated, and who authorized the trial to move to 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 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. 

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").