Alexion Pauses Enrollment in Phase 3 COVID-19 Trial Evaluating Ultomiris

Alexion Pharmaceuticals has halted enrollment for its global phase 3 trial evaluating its monoclonal antibody Ultomiris (ravulizumab-cwvz) in adults with severe COVID-19 who require mechanical ventilation, after interim data showed the drug failed to show efficacy at 29 days post-treatment.

The company said the study will continue for patients already enrolled, including completion of all study visits and planned dosing. The drug is also being evaluated in an ongoing UK study, TACTIC-R, that is assessing various immune-modulation treatments in preventing coronavirus progression. 

Ultomiris is approved in the U.S., EU and Japan for treating adults with paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.