Alexion pauses Phase III Ultomiris trial in COVID-19

US biotech firm Alexion Pharmaceuticals (Nasdaq: ALXN) said late yesterday that it will 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.

Currently approved in the USA, Europe and Japan for adults with paroxysmal nocturnal hemoglobinuria, Ultomiris generated third-quarter 2020 sales of $289.3 million for Alexion, which is the subject of a $39 billion takeover bid from UK pharma major AstraZeneca (LSE: AZN) announced in December.