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Biogen: Primary And Secondary Endpoints Not Met In Natalizumab Phase 2b Study

Biogen Inc. (BIIB) said that the primary and secondary efficacy endpoints were not met in the Phase 2b ACTION 2 study of natalizumab in acute ischemic stroke or AIS, and that the company will not pursue further development of natalizumab. However, Biogen added that it remains committed to advancing treatments for stroke and other acute neurological conditions.

Biogen added that the results of the Phase 2b ACTION 2 study do not impact the benefit-risk profile of natalizumab in approved indications, including multiple sclerosis.

ACTION 2 was a Phase 2b multicenter, double-blind, placebo-controlled, randomized, dose-ranging study with a 90 day follow up to evaluate the safety and efficacy of natalizumab primarily in patients with moderate severity acute ischemic stroke.

In the Phase 2b dose-ranging ACTION 2 study, natalizumab did not demonstrate improvement in clinical outcomes compared to placebo. Both doses of natalizumab were generally well-tolerated and no new or important safety signals were observed.

The primary objective of ACTION 2 was to assess the effects of natalizumab compared to 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 or mRS, and a score of = 95 on the Barthel Index or BI at Day 90.

Biogen noted that in this study, while natalizumab did not significantly decrease the primary endpoint of infarct volume at Day 5, secondary and exploratory endpoints suggested natalizumab treatment improved clinical outcomes compared with placebo which warranted further evaluation.

Michael Ehlers, executive vice president, Research & Development at Biogen, said, "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 (intravenous glibenclamide) for prevention and treatment of edema in large hemispheric infarction, one of the most severe types of stroke."

In the middle of 2018, Biogen plans to initiate a global Phase 3 study of BIIB093 in individuals with large hemispheric infarction, where brain swelling (cerebral edema) often leads to high morbidity and mortality.

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