Ampio Pharmaceuticals said that preliminary results from its AP-014 Phase 1 clinical trial of inhaled Ampion for the treatment of COVID-19 demonstrate a significant reduction in all-cause mortality and shorter hospital stays for patients receiving Ampion compared to standard of care alone. Ampio initiated the Phase 1 trial in October 2020. Based on the initial results, the company said that is planning to advance inhaled Ampion to a Phase 2 study in COVID-19 patients and that it also intends to initiate a Phase 1 trial of nebulized Ampion in patients with “long-haul” COVID-19 symptoms in a home setting by the middle of the second quarter of 2021.
In the AP-014 trial, the rate of all-cause mortality for patients treated with Ampion was 8% compared to 21% for patients given only standard of care. The average hospital stay was 7 days for patients given Ampion versus 11 days for standard of care. In addition, patients treated with Ampion improved and became stable more quickly than patients given standard of care and required less oxygen.
Ampio Pharmaceuticals Chairman and CEO Michael Macaluso said, “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 2 study of inhaled Ampion in COVID-19. It is also important to note that the data was presented to the FDA for guidance as a potential Emergency Use Authorization (EUA) therapy.”
Macaluso added, “The complications from COVID-19 stem not from the virus but from the out-of-control inflammatory immune response it triggers, which remains a problem long after the infection is over. We believe that inhaled Ampion could provide a significant therapeutic benefit for those patients plagued by PASC (“long haul symptoms”). And, because Ampion is a platform biologic, what we learn in our upcoming trial could be applicable to a significant number of diseases displaying similar inflammatory-type characteristics, not just COVID-19.”
Read the Ampio Pharmaceuticals press release.
