Ampio Pharmaceuticals, revealed 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. All patients in the study have now completed treatment, including a follow-up at Day 28 after treatment.
The study not only met its primary endpoint, the final data showed an even greater improvement in all-cause mortality over patients treated using Standard of Care (SOC) than initially reported. Mortality in the SOC group was 24%, while that in the group treated with SOC and Ampion was only 5%, a 78% improvement in all-cause mortality. Preliminary results had been reported in March as 21% for SOC and 8% for Ampion, or a 62% improvement.
Other findings from the study continue to show a positive outcome with Ampion treatment, including:
- Patients who received Ampion required less hospitalization time. The average hospital length of stay was 4 days less for the Ampion group compared to the patients receiving SOC
- Patients treated with Ampion were either stable or showed improvement on a scale of clinical improvement compared to patients treated using SOC. By day 5, 89% of patients who received Ampion were stable or had improvement compared to 77% of patients who received SOC. This trend in improvement with Ampion treatment is noted as early as day 2 and continues to day 5
- Ampion treatment was safe and well-tolerated in all patients. There were no remarkable adverse events with Ampion treatment, and no drug-related serious adverse events were reported
