Eisai Co., Ltd. announced today the company will present research from its robust Alzheimer's disease (AD) pipeline, including the latest findings on lecanemab, Eisai's investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of early AD at the AD/PD 2022 International Conference on Alzheimer's and Parkinson's Diseases (AD/PD) from March 15-20 in Barcelona, Spain and virtually.
The lecanemab data and additional research findings from Eisai's clinical development programs will be featured in 13 presentations. Lecanemab was granted Breakthrough Therapy and Fast Track designations by the U.S. Food and Drug Administration (FDA) in June and December 2021, respectively. Eisai anticipates completing lecanemab's rolling submission of a Biologics License Application for the treatment of early AD to the FDA under the accelerated approval pathway in the first quarter of Eisai's fiscal year 2022, which begins April 1, 2022. Additionally, the readout of the Phase 3 confirmatory Clarity AD clinical trial will occur in the Fall of 2022. Eisai initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data of lecanemab under the prior assessment consultation system in Japan in March 2022.
"Four key presentations at AD/PD 2022 advance our understanding of the mechanism of action of Eisai's investigational anti- Abeta protofibril antibody lecanemab and the therapy's clinical and safety profile, including amyloid related imaging abnormalities, or ARIA, from the Phase 2b study and open-label extension, in the potential treatment of early Alzheimer's disease," said Michael Irizarry, M.D., Senior Vice President, Deputy Chief Clinical Officer, Neurology Business Group, Eisai Inc. "In addition to lecanemab, Eisai's robust pipeline includes compounds targeting the tau pathway, other pathways leading to neurodegeneration, and the testing of combination therapies that may be the optimal approach to treat or even prevent Alzheimer's disease."
The focus on AD has historically been on alleviating cognitive, functional, and behavioral symptoms, but there has been significant progress in understanding the biological mechanisms of the disease. Eisai's investigational pipeline aims to treat the range of underlying pathophysiology, including amyloid, tau and neurodegeneration.
"Because of the robust design of the lecanemab Phase 2b study, Eisai was able to design the Phase 3 confirmatory Clarity AD clinical trial to optimally verify lecanemab's clinical efficacy and safety in early Alzheimer's disease," said Ivan Cheung, Chairman, Eisai Inc., Senior Vice President, President Neurology Business Group and Global Alzheimer's Disease Officer, Eisai Co., Ltd. "Part of the recruitment strategy for the Clarity AD confirmatory trial was to ensure greater inclusion of ethnic and racial populations. While there is still important work to be done in ensuring minority populations' participation in clinical trials, Eisai is proud that approximately 25% of the total U.S. enrollment in Clarity AD consists of African American and Hispanic persons living with early Alzheimer's disease, which mirrors the U.S. Medicare population."
This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agent will successfully complete clinical development or gain health authority approval.