AMPE - Ampio initiates early-stage study with inhaled Ampion in COVID-19 patients

Ampio Pharmaceuticals (AMPE) rises 5% in premarket on moderately higher volume, after it commenced recruiting and enrolling patients in a Phase 1 trial to evaluate inhaled Ampion added to the standard of care ((SOC)) for COVID-19 infected patients hospitalized for respiratory distress.This 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.Last month, the FDA signed-off the study.

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Ampio initiates early-stage study with inhaled Ampion in COVID-19 patients