Biogen discontinuing natalizumab for stroke after Phase IIb miss

Biogen Inc. (NASDAQ:BIIB) discontinued development of natalizumab to treat acute ischemic stroke after the drug missed the primary and secondary endpoints in the Phase IIb ACTION 2 trial in the indication.

Biogen markets natalizumab, a humanized mAb against integrin alpha(4) (VLA-4; CD49D), as Tysabri to treat patients with relapsing forms of multiple sclerosis and for moderately to severely active Crohn’s disease. The company said the ACTION 2 data do not impact the benefit-risk profile of the drug's approved indications.

ACTION 2 enrolled about 270 patients with a clinical diagnosis of acute ischemic stroke and a last known normal time of at least 24 hours prior to initiation of treatment with 300 or 600 mg natalizumab or placebo.

On the trial's primary endpoint, IV natalizumab failed to significantly improve a composite global measure of functional disability based on a score of 0 or 1 point on a modified Rankin scale (mRS) and a score of at least 95 points on the Barthel Index (BI) at day 90 vs. placebo. Secondary endpoints include Stroke Impact Scale-16 (SIS-16) score, Montreal Cognitive Assessment (MoCA) score and NIH Stroke Scale (NIHSS) score.

In May 2017, Biogen acquired IV glibenclamide (BIIB093), an ATP-binding cassette sub-family C member 8 (ABCC8; SUR1) antagonist, from Remedy Pharmaceuticals Inc. (New York, N.Y.) to complement natalizumab in its ischemic stroke portfolio. Biogen plans to start by mid-year a Phase III trial of glibenclamide to treat large hemispheric infarction, a severe form of ischemic stroke that leads to cerebral edema (see BioCentury Extra, May 15, 2017).

Biogen lost $5.97 to $326.89 on Wednesday.