AMPE - Ampio Pharmaceuticals to complete enrollment in early-stage with inhaled Ampion in COVID-19 patients
Ampio Pharmaceuticals ([[AMPE]] +6.1%) says that its Phase I trial of inhaled Ampion (AP-014) in COVID-19 patients proceeded to full open enrollment following clearance by the Safety Monitoring Committee ((SMC)), which found Ampion to be safe and well-tolerated after reviewing results from the first three treatment groups.The trial to complete enrollment of the remaining 34 patients at rapid speed.The US study will enroll 40 patients, randomized 1 to 1, Ampion in addition to SOC versus SOC alone. Safety is the primary end-point and various measurements indicative of efficacy are secondary endpoints.The first three patients inhaling Ampion will be assessed by a Safety Monitoring Committee for an additional three days after the 5 day treatment period, as required by the protocol. If no safety concerns arise, then open enrollment at the speed of recruitment will follow for the remaining patients.In a recent article, published by the Journal of Translational Medicine on the method of action of
For further details see:
Ampio Pharmaceuticals to complete enrollment in early-stage with inhaled Ampion in COVID-19 patients