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January 15, 2021

Alexion pauses COVID-19 trial after drug misses mark

IMAGE | Pixabay.com
By Natalie Missakian

Alexion Pharmaceuticals has put the brakes on a clinical trial that was testing its rare-disease drug Ultomiris in patients who are on ventilators with severe COVID-19.

An independent data monitoring committee recommended pausing the Phase 3 study due to lack of efficacy.

The committee said there was no difference in survival after 29 days among the 122 patients given Ultomiris in combination with other supportive care.

Alexion isn’t nixing the program yet, however, and patients who were already enrolled will be allowed to continue.

“We are disappointed in this initial outcome, but plan to further analyze the data to identify potential subgroups who may benefit and to determine next steps,” said Dr. John Orloff, who heads Alexion research and development. 

Ultomiris, which is approved to treat two rare blood diseases, works by inhibiting an immune protein, C5. The company was investigating whether the drug could ease lung inflammation in patients with severe COVID-19 who needed to be on a ventilator.

Alexion launched the trial after seeing promising anecdotal results in COVID patients given Ultomiris through “compassionate use.” 

Meanwhile, researchers at Cambridge University Hospitals NHS Foundation Trust in the UK are continuing to test whether the drug can prevent progression of  COVID-19 in patients before they are hospitalized. 

Boston-based Alexion, which has a large New Haven research presence, is being acquired by drug giant AstraZeneca for $39 billion.

Contact Natalie Missakian at news@newhavenbiz.com

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