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Eisai: 18-Month, Pre-Specified Analysis Showing Consistent Reduction in Clinical Outcome Measures from a Lecanemab (BAN2401) Phase 2b Clinical Trial in Early Alzheimer’s Disease

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3 minutes

TOKYO, Apr 20, 2021 - (JCN Newswire via SEAPRWire.com) - 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 ext...

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Eisai: Anti-MTBR (Microtubule Binding Region) Tau Antibody E2814 is Selected on Clinical Study for Dominantly Inherited Alzheimer’s Disease by Dian-Tu

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TOKYO, Mar 16, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today that anti-microtubule binding region (MTBR) tau antibody E2814, which was created from collaboration research between Eisai and University College London, has been selected by the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) led by Washington University School of Medicine in St. Louis, as the first investigational medicine among anti-tau drugs for their DIAN-TU tau study.People who have a genetic mutation of dominantly inherited Alzheimer's disease (DIAD); nearly certain to develop Alzheimer's disease (AD), tend to develop symptoms at around the same age their affected parents did, often in their 50s, 40s or even 30s. DIAN-TU launched in 2012 as the first prevention trial for DIAD using anti amyloid-beta (Ab) drugs. Amyloid plaque that consists of Abeta aggregates, as well as neurofibrillary tangles, one of the major AD pathologies, are intraneuronal aggregates of tau and they are believed to spread throughout the brain. The DIAN-TU tau next-generation program will evaluate three anti-tau drugs in clinical studies and has selected E2814 as the first investigational anti-tau drug...

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Eisai to Present Latest Data on Pipeline Assets in the Area of Alzheimer’s Disease and Dementia at the 15th International Conference on Alzheimer’s and Parkinson’s Disease

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2 minutes

TOKYO, Mar 5, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today that the latest data from its Alzheimer's disease (AD) and dementia pipeline, including the investigational anti-amyloid beta (Aß) protofibril antibody lecanemab (Development Code: BAN2401), will be presented at the 15th International Conference on Alzheimer's and Parkinson's Disease (AD/PD2021) to be held virtually from March 9 to 14, 2021.Regarding lecanemab, preliminary analysis results of changes in brain-Aß amounts as observed in subjects of the ongoing open-label extension (OLE) of the Phase II study (Study 201) will be presented orally.Regarding aducanumab, for which applications are currently underway in the U.S., Europe and Japan, Biogen Inc. will conduct presentations on the correlation of amyloid PET and cerebrospinal fluid (CSF) biomarkers in the Phase III studies (EMERGE/ENGAGE), as well as evaluations of the safety and efficacy of aducanumab in early AD. Lecanemab and aducanumab are being jointly developed by Eisai and Biogen.Additionally, regarding the joint research effort with Sysmex Corporation for creation of simplified diagnosis of Alzheimer's disease (AD) u...

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Eisai: Biogen Files New Drug Application for Aducanumab in Japan

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TOKYO, Dec 11, 2020 - (JCN Newswire) - Biogen and Eisai, Co., Ltd. (Tokyo, Japan) announced that Biogen has submitted a Japanese New Drug Application (J-NDA) to the Ministry of Health, Labor and Welfare (MHLW) for aducanumab, an investigational therapy for Alzheimer's disease. Aducanumab, an amyloid beta-targeting antibody, has been shown in clinical trials to remove amyloid beta in the brain and significantly slow clinical decline in patients with Mild Cognitive Impairment (MCI) due to Alzheimer's disease and mild Alzheimer's disease dementia."Japan is the third market where we have applied for regulatory approval for aducanumab, and the filing represents continued progress on our commitment to bring this therapy to patients around the world," said Michel Vounatsos, Chief Executive Officer at Biogen. "Japan has met the challenges of a rapidly-aging population by demonstrating global leadership in setting policies that aim to increase support for Alzheimer's disease patients and caregivers. We look forward to the regulatory review of aducanumab with the hope that, if approved, it could help further manage the impact of this devastating disease.""As Japan has the oldest population i...