Ampio Pharmaceuticals (NYSE American: AMPE), 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.
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.
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