September 21, 2020 -- Ampio Pharmaceuticals has received investigational new drug (IND) authorization from the U.S. Food and Drug Administration, allowing it to conduct additional clinical trials to test Ampion inhalation therapy for patients with COVID-19.
The company's planned phase I, multicenter trial will include 40 patients hospitalized with COVID-19 and experiencing respiratory distress. Ampio will use the trial to evaluate the safety of inhaled Ampion in addition to the standard of care.
Patients with less severe respiratory distress will receive Ampion through a handheld nebulizer, while it will be delivered through mechanical ventilators for patients with severe respiratory distress syndrome.
Ampion is based on an immunomodulatory molecule derived from the N-terminus of the human serum albumin. When inhaled, the drug directly targets lung inflammation that can cause respiratory failure, the company noted.