Eisai Co., Ltd. and Biogen Inc. today announced the publication of an article, A Randomized, Double-Blind Phase 2b Proof of Concept Clinical Trial in Early Alzheimer’s Disease with Lecanemab, an Anti-Abeta Protofibril Antibody, in the 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 (Abeta) 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 3 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 3 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 3 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 Aβ 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 2b clinical trial are encouraging and the scientific community is looking forward to learning more in the Phase 3 studies, Clarity AD and AHEAD 3-45, currently underway.”
“These supportive findings from the lecanemab Phase 2b study and the initiation of two Phase 3 studies are exciting for the field and provide the opportunity to further explore the key role of the amyloid beta pathway in the pathophysiology of Alzheimer’s disease,” said Michael Irizarry, M.D., Vice President, Deputy Chief Clinical Officer, Neurology Business Group, Eisai Inc. “Eisai’s precision pipeline approach envisions an Alzheimer’s disease treatment paradigm based on a person’s pathophysiological biomarker profile along the disease continuum. We are working to advance lecanemab and our other targeted investigational compounds as quickly as possible in our commitment to bringing solutions to patients and their families.”
For more information, visit https://www.eisai.com/news/2021/pdf/enews202128pdf.pdf.
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