Enrollment halted in global phase III trial of Ultomiris in COVID-19.- Alexion Pharmaceuticals

Alexion Pharmaceuticals announced the decision to pause further enrollment in the global Phase III study of Ultomiris (ravulizumab-cwvz) in adults with severe COVID-19 requiring mechanical ventilation. This decision is based on the recommendation of an independent data monitoring committee (IDMC), following their review of data from a pre-specified interim analysis. The IDMC recommended that additional enrollment be paused, pending further analysis of the data, due to lack of efficacy when Ultomiris was added to best supportive care, compared to best supportive care alone. There were no new safety findings observed. The study will continue for patients already enrolled, including completion of all study visits and planned Ultomiris dosing according to the study protocol. The IDMC’s recommendation was based on a pre-planned interim analysis of the primary endpoint – survival at Day 29 – once 122 patients completed the 29-day primary evaluation period. No secondary endpoints were analyzed as part of the interim analysis. In the UK, the TACTIC-R platform study led by Cambridge University Hospitals NHS Foundation Trust, which includes an Ultomiris cohort, is evaluating the potential of earlier immune modulatory treatment (hospitalized patients not requiring mechanical ventilation) in preventing progression of the virus, including reducing the need for ICU admission and ventilation. This independent study remains ongoing.