According to Ampio Pharmaceuticals, the Drugs Controller General of India (DCGI) has approved the protocol for AP-019 Phase 2 trial of the company’s inhaled Ampion biologic for the treatment of respiratory distress caused by COVID-19. Ampio announced in June 2021 that it had initiated the Phase 2 AP-019 clinical trial in the US and noted that the FDA had approved adding at least one trial site in India which was experiencing a higher incidence of COVID-19.
The primary endpoint for the Phase 2 trial is reduction in all-cause mortality compared to an inhaled placebo at Day 28. In a Phase 1 trial of inhaled Ampion completed earlier this year, the mortality rate for patients who received inhaled Ampion in addition to standard of care was 5% compared to 24% for patients who received only standard of care, a 78% reduction in all-cause mortality.
Ampio President and CEO Mike Macaluso commented, “More than a year and a half into the pandemic, healthcare practitioners still lack effective and easy-to-use therapies to treat the severe and often fatal respiratory distress experienced by many COVID-19 patients. We are grateful for the DCGI’s swift attention and believe their decision underscores the critical medical need for Ampion as a potential treatment option.”
Read the Ampio Pharmaceuticals press release.
