BIIB - Biogen/Eisai's lecanemab shows mixed results in mid-stage Alzheimer's Disease study

Biogen (BIIB) and Eisai (ESALF) announce results from Phase 2b trial in Alzheimer's Disease ((AD)) in peer-reviewed journal Alzheimer's Research and Therapy.The manuscript describes results from Study 201, a Phase 2b proof-of-concept clinical trial that explored the impact of treatment with lecanemab (BAN2401) on reducing brain amyloid beta (A?) and clinical decline.Background: BAN2401-G000-201 aimed to establish the effective dose 90% (ED90). A total of 854 randomized subjects were treated (lecanemab, 609; placebo, 245).Results: At 12?months, the 10-mg/kg biweekly ED90 dose showed a 64% probability to be better than placebo by 25% on Alzheimer’s Disease Composite Score ((ADCOMS)), which missed the 80% threshold for the primary outcome.Outcome of key secondary endpoints are as follows. At 18?months, 10-mg/kg biweekly lecanemab reduced brain amyloid (?0.306 SUVr units) while showing a drug-placebo difference in favor of active treatment by 27% and 30% on ADCOMS, 56% and 47% on ADAS-Cog14, and 33% and 26% on CDR-SB versus placebo.CSF biomarkers

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Biogen/Eisai's lecanemab shows mixed results in mid-stage Alzheimer's Disease study