Clinical Data

• The primary and secondary efficacy endpoints were not met in the ACTION 2 study

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 (mRS) and a score of ≥ 95 on the Barthel Index (BI) at Day 90. The mRS measures independence with specific tasks pre- and post-stroke. BI is a scale that consists of 10 items that measure activities of daily living and mobility.Natalizumab was previously evaluated in AIS in the Phase 2a ACTION study. In this study, although 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.