Ampio Pharmaceuticals said that the FDA has cleared its IND for clinical trials of an inhaled formulation of its Ampion anti-inflammatory biologic in patients with COVID-19. The company had announced its plans to develop Ampion for the treatment of COVID-19 in March 2020.
According to Ampio, preclinical toxicology studies demonstrated that Ampion would be safe for inhaled delivery and could be effective in reducing and repairing lung damage.
The Phase I trial is expected to enroll 40 hospitalized COVID-19 patients who will receive nebulized Ampion plus standard of care. The study will include patients with acute respiratory distress syndrome (“ARDS”) who will get Ampion through mechanical ventilators as well as patients will less severe respiratory distress who will get Ampion via a hand-held nebulizer.
Read the Ampio press release.
