Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, 'Eisai') announced today that three oral presentations and eight poster presentations, highlighting the latest data on its Alzheimer's disease / dementia pipeline including anti-amyloid beta (A) protofibril antibody BAN2401, orexin receptor antagonist lemborexant and a simple blood diagnostic for Alzheimer's disease (AD), will be given at the 12th Clinical Trials on Alzheimer's Disease (CTAD) conference taking place in San Diego, California in the United States, from December 4 to 7, 2019.
BAN2401 is being jointly developed by Eisai and Biogen Inc. (Headquarters: Cambridge, Massachusetts, United States). In addition, the simple blood diagnostics for AD are being jointly developing by Eisai and Sysmex Corporation (Headquarters: Hyogo, Japan, 'Sysmex').
For BAN2401, the persistance of brain A levels in patients with early AD at the beginning of the open label extension phase of the Phase II study (Study 201) will be presented in Late-Breaking Oral Communications Session. Study 201 is a first late-stage study which successfully demonstrated the potential disease-modifying effects on both clinical function and A accumulation in the brain. In addition, the study design and current status of ongoing Clarity AD (Study 301) will be presented.
Meanwhile, for the investigational sleep-wake regulation agent lemborexant, the further data analysis results from Phase II clinical study (Study 202) for AD patients with irregular sleep-wake rhythm disorder (ISWRD) will be given.
In addition, regarding the creation of the simplified blood diagnostics for AD, jointly developed with Sysmex, the latest data of the fully automated protein assay system using the Sysmex's automated protein measurement immunoassay platform HISCLTM series will be presented.
Eisai is aiming to realize prevention and cure of dementia through a holistic approach to dementia drug discovery research based on a foundation of over 35 years of experience of drug discovery activities in the area of Alzheimer's disease / dementia. Eisai is striving to create innovative medicines as soon as possible in order to further contribute to addressing the unmet medical needs of, as well as increasing the benefits provided to, patients and their families.
Contact:
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About BAN2401
BAN2401 is a humanized monoclonal antibody for Alzheimer's disease (AD) that is the result of a strategic research alliance between Eisai and BioArctic. BAN2401 selectively binds to neutralize and eliminate soluble, toxic A aggregates (protofibril) that are thought to contribute to the neurodegenerative process in AD. As such, BAN2401 may have the potential to have an effect on disease pathology and to slow down the progression of the disease. Eisai obtained the global rights to study, develop, manufacture and market BAN2401 for the treatment of AD pursuant to an agreement concluded with BioArctic in December 2007. Currently, a global clinical phase III study (Clarity AD) of BAN2401 in early AD is underway.
About the Joint Development Agreement between Eisai and Biogen for AD
Eisai and Biogen are widely collaborating on the joint development and commercialization of AD treatments. Eisai serves as the lead in the co-development of BAN2401, an anti-A protofibril antibody, while Biogen serves as the lead for co-development of aducanumab, Biogen's investigational anti-A antibody for patients with AD, and the companies plan to pursue marketing authorizations for the two compounds worldwide. If approved, the companies will also co-promote the products in major markets, such as thep United States, the European Union and Japan.
About Lemborexant
Lemborexant, an orexin receptor antagonist, is Eisai's in-house discovered and developed small molecule that inhibits orexin neurotransmission by binding competitively to the two subtypes of orexin receptors (orexin receptor 1 and 2). Faster on/off receptor kinetics of lemborexant to orexin receptor 2, which also suppresses non-REM sleep, indicate its potential to be facilitate the onset and maintenance of sleep. As a result of clinical studies, the effect of lemborexant are suggested not only for primary insomnia but also for insomnia which the diseases, such as depression, associated with. Eisai has submitted new drug applications seeking approval of lemborexant for use in the treatment of insomnia disorder in the United States (December 2018), Japan (March 2019), and Canada (August 2019), respectively. Additionally, a Phase II clinical study of lemborexant in patients with ISWRD associated with mild to moderate Alzheimer's dementia is underway.
About collaboration between Eisai and Sysmex
Eisai and Sysmex have entered into a comprehensive non-exclusive collaboration agreement aimed at the creation of new diagnostics in the field of dementia in February, 2016. Leveraging each other's technologies and knowledge, the two companies aim to discover next-generation diagnostics that will enable early diagnosis, selection of treatment options and the regular monitoring of the effects of treatment for dementia.
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