Alexion pauses Phase III ULTOMIRIS COVID-19 trial enrolment
Alexion has paused further enrolment in the global Phase III study of ULTOMIRIS (ravulizumab-cwvz) in adult COVID-19 patients requiring mechanical ventilation, due to lack of efficacy.
The decision was made following the recommendation of an independent data monitoring committee (IDMC), which reviewed data from a pre-specified interim analysis. The IDMC recommended that additional enrolment be paused, pending further analysis of the data, due to lack of efficacy when ULTOMIRIS was added to best supportive care, compared with best supportive care alone.
There were no new safety findings observed, and the study will continue for patients already enrolled, including completion of all study visits and planned ULTOMIRIS dosing according to the study protocol.
Alexion’s ULTOMIRIS is a long-acting C5 inhibitor currently indicated for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH), and the treatment of adults and children aged one month and older with atypical haemolytic uremic syndrome (aHUS).
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 the treatment in halting progression of the virus in hospitalised patients not requiring mechanical ventilation. This independent study remains ongoing.
Dr John Orloff, Executive Vice President and Head of Research and Development at Alexion, said: “We would like to thank the patients and their families, as well as investigators and healthcare professionals, who were essential to this study. We greatly value their contributions to help investigate potential ways to address this devastating pandemic.
“While initial anecdotal reports from compassionate use cases were promising, these results demonstrate the importance of conducting controlled clinical trials to fully evaluate the potential of new treatment approaches and generate the necessary evidence to make informed decisions.
“We are disappointed in this initial outcome, but plan to further analyse the data to identify potential subgroups who may benefit and to determine next steps. In addition, we remain fully committed to our efforts to serve the rare disease community and to continuing to provide ULTOMIRIS to the patients who currently rely on it.”
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