Topline results of a phase 2b study of multiple sclerosis (MS) drug natalizumab (Tysabri, Biogen) in acute ischemic stroke show no improvement in clinical outcomes compared to placebo, the company announced.
A well-documented inflammatory response after stroke leads to immune cells entering the brain, and a large body of preclinical data suggests that this is harmful. Natalizumab is a monoclonal antibody directed against α4-integrin, a key molecule in this inflammatory process and thus an attractive target for new stroke therapies.
Natalizumab was previously evaluated in acute ischemic stroke in the phase 2a ACTION study. In this study, reported from the International Stroke Conference 2016 by Medscape Medical News, natalizumab did not significantly decrease the primary endpoint of infarct volume at day 5. However, secondary and exploratory endpoints suggested that natalizumab treatment improved clinical outcomes compared with placebo, which led to the phase 2b ACTION study.
The ACTION 2 study evaluated the safety and efficacy of natalizumab in 270 patients with primarily moderate severity acute ischemic stroke with last known normal (LKN) at 24 hours or less before treatment initiation. Patients received natalizumab (300 mg or 600 mg) or placebo within 9 hours of LKN or between 9 and 24 hours after LKN, with a 90-day follow-up period.
The primary objective of ACTION 2 was to compare the effects of natalizumab with those of placebo on clinical measures of independence and activities of daily living. The primary endpoint was a composite global measure of functional disability based on a score of 0 to 1 on a modified Rankin Scale and a score of 95 or greater on the Barthel index at 90 days.
Both doses of natalizumab were generally well tolerated, and no new or important safety signals were observed. However, the study failed to meet primary and secondary efficacy endpoints, Biogen said, without giving further details.
The company plans to release detailed results of the phase 2b ACTION 2 study in a future scientific forum, the company statement notes.
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