Ampio recently announced that it received FDA investigational new drug designation to proceed with clinical trials of its Ampion inhaler for patients with COVID-19 respiratory distress.
The company is expanding on its recent successful Phase I trial that administered the drug intravenously to COVID-19 patients. The new Phase I trial of inhaled Ampion will total 40 patients and assess the safety and efficacy of the inhaled drug as a standard of care for COVID-19 infected patients that are hospitalized due to respiratory distress.
Ampion will be administered through a handheld nebulizer and inhaled to allow the drug to directly target and attenuate inflammation in the lungs, according to the company. The clinical trial will study the effects of inhaled Ampion while emphasizing early intervention treatment throughout the progression of COVID-19.
Toxicology studies of the drug have demonstrated that Amption is safe for inhalation and has effectively reduced signaling proteins responsible for tissue damage and pulmonary complications.