TOKYO, Oct 28, 2020 - (JCN Newswire) - Eisai Co., Ltd. announced today that the company will conduct a total of 7 presentations, including the latest data of the investigational anti-amyloid beta (Abeta) protofibril antibody lecanemab (Development Code: BAN2401), at the 13th Clinical Trials on Alzheimer's Disease (CTAD) conference to be held virtually from November 4 to 7, 2020. Regarding lecanemab, Eisai will conduct four oral presentations. The first oral presentation will cover clinical study design and initial screening results of the newly initiated Phase III clinical study AHEAD 3-45 for preclinical Alzheimer's disease (AD) patients. The second oral presentation will cover the latest analysis results on expression of amyloid-related imaging abnormalities-edema (ARIA-E) from the Phase II study (Study 201) conducted on early AD patients. The third oral presentation will cover changes in brain-Abeta amounts and preliminary analysis results on ARIA-E expression as observed in the first 12-month treatment period of the ongoing open-label extension (OLE) study of Study 201. The fourth oral presentation will cover baseline characteristics of currently enrolled subjects in the Phase III study Clarity AD being conducted on early AD patients. Other presentation topics include the effectiveness of lemborexant on irregular-sleep-wake- rhythm-disorder (ISWRD) in AD as observed in mouse models in relation to clinical trials, as well results from a Phase I, First-In-Human (FIH), Single Ascending Dose (SAD) study of the novel anti-microtubule binding region (MTBR) tau antibody E2814.
Regarding aducanumab, Biogen Inc. (Headquarters: Cambridge, Massachusetts, United States) will conduct an oral presentation on the design of its Phase IIIb redosing study EMBARK. A Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA), for approval of aducanumab as an AD treatment, was accepted and received priority review designation in August 2020.
Lecanemab and aducanumab are being jointly developed by Eisai and Biogen Inc. Regarding the joint research effort with Sysmex Corporation for creation of simplified diagnosis of AD using blood, a poster will be presented on prediction of Amyloid Positivity Defined by Amyloid PET Centiloid through Plasma Aβ Ratio Measurement on a Fully Automated Immunoassay, HISCLTM*. 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. *HISCLTM is a trademark of Sysmex Corporation.
Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to address unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology. As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.
For more information about Eisai Co., Ltd., please visit https://www.eisai.com
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