Alexion Pharmaceuticals Plans Phase 3 Trial of Ultomiris for Severe COVID-19

Alexion Pharmaceuticals plans to initiate a global phase 3 clinical trial to evaluate Ultomiris (ravulizumab-cwvz) in hospitalized patients with severe COVID-19.

The trial will evaluate the drug in approximately 270 adults hospitalized with severe pneumonia or acute respiratory distress syndrome.

Ultomiris is approved in the U.S. for adults with two rare blood diseases — paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.

Alexion will begin enrollment in May for the trial in countries with high numbers of cases to evaluate the impact of the C5 protein complement inhibitor on survival, duration of mechanical ventilation and hospital stay compared to best supportive care.

Alexion is also offering its blockbuster complement inhibitor Soliris (eculizumab) as a possible treatment of COVID-19 patients. It is supplying the drug on a compassionate use basis and has opened an expanded access program in the U.S. and France for severe COVID-19 pneumonia. — Jordan Williams