Ampio Pharmaceuticals has announced that the final results from the AP-014 Phase 1 trial of inhaled Ampion in COVID-19 patients demonstrated a greater reduction in all-cause mortality than was seen in the preliminary results. In March 2021, Ampio reported that preliminary data from the trial showed a 62% reduction in all-cause mortality. After all patients completed treatment, the reduction was found to be 78%. Patients in the study who were treated with standard of care alone had 24% mortality; patients treated with inhaled Ampion in addition to standard of care had a 5% mortality rate.
Final results for hospitalization time were consistent with the preliminary results, with patients receiving Ampion staying in the hospital 4 fewer days than patients who did not receive Ampion. Inhaled Ampion was also found to be well-tolerated, with no significant adverse events.
Ampio President and CEO Michael Macaluso commented, “These are strong results from a Phase 2 trial, and we are looking forward to continuing immediately with the commencement of our double-blind placebo-controlled Phase 2 trials utilizing Ampion in both in an inhaled form for COVID-19 respiratory distress and intravenously for more systemic symptoms of COVID-19. If these Phase 2 studies confirm the efficacy results seen in our Phase 1 trials, I can envision moving forward quickly with an application for Emergency Use Authorization for Ampion in treating COVID-19.”
Read the Ampio Pharmaceuticals press release.
