Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, 'Eisai') announced today that the company will conduct a total of 9 presentations, including the latest data of the investigational anti-amyloid beta protofibril antibody BAN2401, at the Alzheimer's Association International Conference (AAIC) to be held virtually from July 27 to 31, 2020.
Regarding BAN2401, the clinical study design of the newly initiated Phase III clinical study AHEAD 3-45 for preclinical Alzheimer's disease (AD) patients will be presented orally. The latest data on the analysis of occurrence of amyloid-related imaging abnormalities-edema (ARIA-E) and brain A levels from the ongoing open-label extension study (OLE) portion of the Phase II study (Study 201) will also be presented.
The safety and efficacy results from a Phase II clinical study on lemborexant (orexin receptor antagonist) targeting Irregular Sleep Wake Rhythm Disorder (ISWRD) associated with AD will be presented.
Eisai is also planning to host a satellite symposium 'Development of the A/T/N/x Classification System for Different Context of Use Across the Alzheimer's Disease Continuum: State-of-the-Art and future Perspectives for Clinical Practice and Therapy Development'. Dr. Jeffrey Cummings (Chair), Dr. Clifford Jack, and Dr. Kaj Blennow, three renowned AD researchers and clinicians, will provide a comprehensive overview of the significance and conceptual framework of the A/T/N/x categorization system in the AD continuum. Finally, they will hold a discussion on the future outlook of this classification system for Alzheimer's pharmacological trials and clinical practice.
Regarding aducanumab, for which submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval as an Alzheimer's Disease treatment was completed in July 2020, Biogen Inc. (Headquarters: Cambridge, Massachusetts, United States) will conduct an oral presentation of the previously publicized topline results of Phase III studies EMERGE and ENGAGE. This data has been shared at prior medical congresses.
BAN2401 and aducanumab are being jointly developed by Eisai and Biogen Inc.
Eisai aims to realize the prevention and cure of dementia through a multi-dimensional and holistic approach with a foundation of over 35 years of experience of drug discovery activities in the area of AD and dementia. Eisai strives to create innovative medicines as soon as possible to further contribute to addressing the unmet medical needs of, as well as increasing the benefits provided to, those living with the disease and their families.
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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 AB (Headquarters: Sweden). 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. BAN2401 is being jointly developed by Eisai and Biogen Inc. The National Institutes of Health, National Institute of Aging are providing funding for the A45 Study (grant number R01AG061848) and A3 Study (grant number R01AG054029).
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, may influence lemborexant's potential to facilitate improvements in sleep onset and maintenance. In June 2020, lemborexant was launched under the product name DAYVIGOTM in the U.S. for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance and in July 2020, it was launched under the product name DAYVIGO in Japan for the treatment of insomnia. Eisai has submitted new drug applications seeking approval of DAYVIGO in Canada, Australia and Hong Kong. In addition, a Phase II clinical study of lemborexant in patients with ISWRD associated with mild to moderate Alzheimer's dementia is underway.
About Aducanumab
Aducanumab (BIIB037) is an investigational human monoclonal antibody studied for the treatment of Alzheimer's disease. Based on clinical data, aducanumab has the potential to impact underlying disease pathophysiology, slow cognitive and functional decline and provide benefits on patients' ability to perform activities of daily living, including conducting personal finances, performing household chores, such as cleaning, shopping and doing laundry, and independently traveling out of the home. If approved, aducanumab would be the first treatment to meaningfully change the course of the disease for individuals living with Alzheimer's.
Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. Since October 2017 Biogen and Eisai have collaborated on the development and commercialization of aducanumab globally.
EMERGE and ENGAGE were Phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate the efficacy and safety of aducanumab. The primary objective of the studies was to evaluate the efficacy of monthly doses of aducanumab as compared with placebo in reducing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score. Secondary objectives were to assess the effect of monthly doses of aducanumab as compared to placebo on clinical decline as measured by the Mini-Mental State Examination (MMSE), Alzheimer's Disease Assessment Scale-Cognitive Subscale 13 Items (ADAS-Cog 13) and Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory Mild Cognitive Impairment Version (ADCS-ADL-MCI).
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