Ampio Pharmaceuticals a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, recently revealed preliminary positive results in its AP-014 Phase I clinical trial utilizing inhaled Ampion in treating respiratory distress in patients as a result of COVID-19. The Company also outlined its progress toward initiating a Phase I clinical trial using inhaled Ampion for treating those suffering lingering respiratory effects after COVID-19 infection, the so-called COVID-19 “long haulers,” as well as its continued research focusing on the use of Ampion in kidney and pediatric diseases.
“We shared these promising results with the FDA in our recent request to expand that trial. The FDA’s response recommended that we forego our planned unblinded expansion of the current trial and move directly to a randomized, double-blinded, placebo-controlled Phase II study of inhaled Ampion in COVID-19,” said Michael Macaluso, Chairman and Chief Executive Officer of Ampio Pharmaceuticals. “It is also important to note that the data was presented to the FDA for guidance as a potential Emergency Use Authorization (EUA) therapy.”
Preliminary results from the AP-014 Phase I trial of inhaled Ampion indicate:
- Ampion demonstrated an improvement in all-cause mortality in COVID-19 patients compared to standard of care (SOC). A lower all-cause mortality rate of 8% is observed for the Ampion treatment group, compared to 21% in standard of care alone.
- Patients who received Ampion required less hospitalization time. The average hospital length of stay was 7 days for the Ampion group compared to 11 days for standard of care patients.
- Patients who received Ampion required less oxygen than standard of care alone, and 86% of Ampion patients were stable or had improvement compared to 75% of SOC patients.
- More patients who received Ampion were stable or had improvement on a scale of clinical improvement compared to standard of care alone. By day 5, 86% of patients who received Ampion were stable or had improvement compared to 75% of standard of care patients. This trend in improvement with Ampion treatment is noted as early as day 2 and continues to day 5.
- Adverse events were the same between Ampion and standard of care, and no drug-related serious adverse events have been reported.
In commenting on the preliminary positive results in the AP-014 Phase I clinical trial of inhaled Ampion, Dr. David Cornutt, MD, Chairman, Department of Emergency Medicine, Regional West Health Services, and a Medical Monitor on the study, said, “The scientific findings we have reviewed thus far are fascinating and very encouraging. While we are still looking at preliminary data from a small sample size, the safety signals look strong, and I look forward to moving into the efficacy phases to come.”