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Biogen Halts Development of Tysabri for Acute Ischemic Stroke after Phase IIb Failure

Biogen said today it will scrap development of Tysabri® (natalizumab) for a new indication of acute ischemic stroke (AIS) after the marketed drug failed a Phase IIb trial.

Tysabri missed its primary and secondary efficacy endpoints in the Phase IIb ACTION 2 study, Biogen said.

Biogen did not detail those results, saying that detailed findings from ACTION 2 would be presented at an unspecified “future scientific forum.”

“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,” Michael Ehlers, M.D., Ph.D., evp, R&D at Biogen, said in a statement.

Later this year, Biogen plans to initiate a global Phase III study of BIIB093 (intravenous glibenclamide) in patients with a severe form of stroke, large hemispheric infarction (LHI).

In preclinical studies, BIIB093 was shown to block SUR1-TRPM4 (sulfonylurea receptor 1–transient receptor potential melastatin 4) channels that mediate stroke-related brain swelling. According to Biogen, clinical proof-of-concept studies demonstrated the potential of BIIB093 to reduce brain swelling, disability, and the risk of death in patients with LHI.

Biogen acquired BIIB093, formerly known as Cirara™ and glyburide, from Remedy Pharmaceuticals in May 2017, agreeing to pay $120 million upfront and undisclosed additional milestone payments and royalties.

“As pioneers in neuroscience, Biogen remains committed to developing treatments for people with acute neurological conditions, including stroke,” Ehlers added.

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