Ampio Pharmaceuticals has announced the initiation of the AP-019 Phase 2 clinical trial of inhaled Ampion for the treatment of respiratory distress in patients with COVID-19. The company said that it has also received the okay from the FDA to add at least one trial site in India which currently has a high incidence of COVID-19; the initial location was in the US.
According to the study record, the AP-019 trial is expected to enroll 200 adult COVID-19 patients who will receive either inhaled Ampion (“the low molecular weight filtrate of human serum albumin with the in vitro ability to modulate inflammatory cytokine levels”) or inhaled placebo.
Earlier this year, Ampio announced that a Phase 1 trial of inhaled Ampion demonstrated a significant reduction in all-cause mortality compared to standard of care. In that study, the mortality rate for patients treated with inhaled Ampion in addition to standard of care was 5%, while the mortality rate for patients treated with standard of care alone was 24%.
Ampio President and CEO Michael Macaluso said, “We saw strong, positive results in our Phase 1 trial, reducing all-cause mortality in COVID-19 respiratory distress by 78%. If this Phase 2 study further confirms the efficacy results seen in our Phase 1 study, I can envision moving forward quickly with an application for Emergency Use Authorization for Ampion in treating patients suffering from respiratory distress due to COVID-19.”
Read the Ampio Pharmaceuticals press release.
