Biogen Inc. ((BIIB)), Biogen ((CC:HTER)) announced an update on their ongoing clinical study.
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Biogen Inc. (BIIB) and Eisai Inc. are conducting a pivotal study titled ‘A Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study With an Open-Label Extension Phase to Confirm Safety and Efficacy of BAN2401 in Subjects With Early Alzheimer’s Disease.’ The study aims to confirm the safety and efficacy of lecanemab in treating early Alzheimer’s disease by comparing its effects to a placebo over 18 months, focusing on changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB).
The intervention being tested is lecanemab, a drug administered biweekly as an intravenous infusion and in various subcutaneous doses. Its purpose is to slow the progression of early Alzheimer’s disease.
This interventional study is randomized with a parallel assignment model. It employs quadruple masking, meaning that the participant, care provider, investigator, and outcomes assessor are unaware of the treatment allocations. The primary purpose of the study is treatment.
The study began on March 27, 2019, and is currently active but not recruiting. The primary completion date was initially set for 18 months post-start, with the last update submitted on June 30, 2025. These timelines are crucial for tracking the study’s progress and anticipating results.
The outcome of this study could significantly influence Biogen’s stock performance and investor sentiment, especially given the competitive landscape of Alzheimer’s treatments. Positive results could enhance Biogen’s market position, while negative outcomes might benefit competitors.
The study is ongoing, with further details available on the ClinicalTrials portal.