Lecanemab phase 3 Clarity AD study in early Alzheimer’s disease meets primary and all key secondary endpoints with high statistical significance

Stockholm, September 28, 2022 – BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced positive topline results for the large global Phase 3 confirmatory Clarity AD study in 1,795 subjects. The study met the primary endpoint (CDR-SB 1 : Clinical Dementia Rating-Sum of Boxes) showing a highly statistically significant reduction of clinical decline. All key secondary endpoints were also met demonstrating highly statistically significant results. Clarity AD is a clinical trial of lecanemab (development code: BAN2401), an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD), with confirmed presence of amyloid pathology in the brain. The relative risk in Clarity AD of the main side effect associated with anti-amyloid therapies, ARIA, was within expectations. Eisai will discuss this data with regulatory authorities in the U.S., Japan and Europe with the aim to file for traditional approval in the US and for marketing authorization applications in Japan and Europe by the end of the first quarter of 2023. Additionally, Eisai will present the Clarity AD study results on November 29, 2022, at the Clinical Trials on Alzheimer’s Disease conference (CTAD) and publish the findings in a peer-reviewed medical journal.

The release as fetched from its publisher. bioarctic.com ↗