Ampion Study Advances to 3rd Group of COVID-19 Patients with Respiratory Distress

Ampio Pharmaceuticals announced the third group in the Phase I inhaled Ampion™ clinical study is being treated following clearance by the Safety Monitoring Committee (SMC) who found Ampion to be safe and well-tolerated after reviewing the results from the first and second treatment groups.

"Ampion is being administered to patients by inhalation, allowing the drug to directly target and attenuate inflammation in the lungs, using a hand-held nebulizer for COVID-19 patients early in the disease and non-invasive ventilation (face mask) and mechanical ventilation (intubation) if their disease state is more severe,” Michael Macaluso, Ampio's, President and CEO, clarified specific features of this clinical trial. “This US based study will enroll 40 patients, randomized 1 to 1, inhaled Ampion versus Standard of Care (SOC), with each patient inhaling 8 ml doses of Ampion four (4) times a day for five (5) days. Safety is the primary end point and various measurements indicative of efficacy are secondary endpoints. Each of the first three patient groups receiving inhaled Ampion are assessed by the SMC for an additional three days after the 5 day treatment period (as inhalation is a new method of administration of Ampion cleared for clinical use by the FDA) and if no safety concerns arise for this third group, the trial will accelerate to complete enrollment of the remaining 34 patients at the speed of recruitment."