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Biogen halts Tysabri trial after failure in acute ischemic stroke

Published on 08/02/18 at 09:56am

Biogen has halted its investigation into the efficacy of its humanised monoclonal antibody Tysabri (natalizumab) in the treatment of acute ischemic stroke (AIS) after it failed to meet its primary and secondary endpoints in a Phase 2b trial, demonstrating no improvement over placebo.

The trial randomised 270 patients to receive either one or two doses of Tysabri or placebo, starting within nine hours of last known normal (LKN), or between nine and 24 hours after. The study’s primary endpoint was composite global measure of functional disability, as measured on a modified Rankin scale with a score of 0 to 1, as well as a score of at least 95 on the Barthel Index at day 90.

The company noted that detailed results from the trial will be revealed at a future medical conference, adding that the results of the failed study do not impact the safety profile of the drug in its existing indications.  

As part of Biogen’s multiple sclerosis pipeline, Tysabri generated almost $2 billion in sales throughout 2017.

“As pioneers in neuroscience, Biogen remains committed to developing treatments for people with acute neurological conditions including stroke,” commented Biogen’s Executive Vice President of R&D Michael Ehlers. “While we are disappointed with the ACTION 2 study results, we have furthered our knowledge of the disease and will continue to pursue innovative approaches in this area, including BIIB093 for prevention and treatment of oedema in large hemispheric infarction.”

On this note, Biogen plans investigate the efficacy of BIIB093, an intravenous glibenclamide formulation, in patients with large hemispheric infarction by conducting a study later this year.

Matt Fellows

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