18-month, pre-specified analysis showing consistent reduction in clinical outcome measures from a lecanemab (BAN 2401) phase IIb clinical trial in early Alzheimer’s disease.- Eisai + BioGen

Eisai Co., Ltd. and Biogen Inc. announced the publication of an article," A Randomized, Double-Blind Phase IIb Proof of Concept Clinical Trial in Early Alzheimer’s Disease with Lecanemab, an Anti-A? Protofibril Antibody", in the peer-reviewed journal Alzheimer’s Research and Therapy. The manuscript describes results from Study 201, a Phase IIb proof - of-concept clinical trial that explored the impact of treatment with lecanemab (BAN 2401) on reducing brain amyloid beta (A beta) and clinical decline. The manuscript concluded that the pre-specified analysis showed consistent reduction of clinical decline across several clinical and biomarker endpoints at the highest doses, which the Phase III clinical trial Clarity AD aims to confirm. The results of Study 201 were presented at the Alzheimer’s Association International Conference and Clinical Trials on Alzheimer's Disease in 2018. The lecanemab Clarity AD Phase III clinical trial completed enrollment last month with 1,795 symptomatic patients with early Alzheimer’s disease (AD) . Clarity AD is a placebo-controlled, double-blind, parallel-group, 18-month study with an open-label extension phase designed to confirm safety and efficacy of lecanemab in subjects with early AD. Additionally, the Phase III AHEAD 3-45 clinical study is currently exploring lecanemab in individuals with preclinical AD , defined as patients that are clinically asymptomatic, but have intermediate or elevated brain A beta levels. “Amyloid beta aggregates are thought to be more toxic than monomers, and we hypothesized that reducing these could represent an effective treatment approach in early stages of Alzheimer’s disease, ” said Jeffrey Cummings, M.D., ScD, lecanemab manuscript author and director at the Chambers -Grundy Center for Transformative Neuroscience, Department of Brain Health, School of Integrated Health Sciences, University of Nevada Las Vegas. “These results from lecanemab’s Phase IIb clinical trial are encouraging and the scientific community is looking forward to learning more in the Phase III studies, Clarity AD and AHEAD 3-45, currently underway.” See-"A randomized, double-blind, phase IIb proof-of-concept clinical trial in early Alzheimer’s disease with lecanemab, an anti-A beta protofibril antibody"- Authors:Chad J. Swanson, Yong Zhang, Shobha Dhadda, Jinping Wang, June Kaplow,et al., Citation:Alzheimer's Research & Therapy 2021 13:80 Published on: 17 April 2021.