Mar 22, 2019 11:37 JST

Source: Eisai

Eisai's Initiation of Phase III Clinical Trial of BAN2401 in Early Alzheimer's Disease

TOKYO, Mar 22, 2019 - (JCN Newswire) - Eisai Co., Ltd. announced that a global Phase III clinical study (Clarity AD/Study 301) of BAN2401, an anti-amyloid beta protofibril antibody, in patients with early Alzheimer's disease has been initiated. BAN2401 is being jointly developed by Eisai and Biogen Inc.

Clarity AD is a global placebo-controlled, double-blind, parallel-group, randomized study in 1,566 patients with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild Alzheimer's disease dementia (collectively known as early AD) with confirmed amyloid pathology in the brain. After discussion with regulatory agencies based on the results of a Phase II clinical study (Study 201), a single Phase III clinical study is being initiated to support a filing for BAN2401.

The treatment group will be administered a dosage of 10 mg/kg bi-weekly of BAN2401, with patients allocated in a 1:1 ratio to receive either placebo or the treatment group. The primary endpoint is the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment. Respective changes from baseline to 18 months of treatment in the AD composite score (ADCOMS), AD Assessment Scale-Cognitive Subscale (ADAS-cog), and brain amyloid levels as measured by amyloid positron emission tomography (PET) have been set as key secondary endpoints.

Eisai aims to create innovative medicines for Alzheimer's disease as soon as possible in order to further contribute to addressing the unmet medical needs of, as well as potentially increasing the benefits provided to, patients and their families.

Contact:
Public Relations Department,
Eisai Co., Ltd.
+81-3-3817-5120
Source: Eisai
Sectors: BioTech

Copyright ©2024 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.

Related Press Release


Eisai to Divest Rights for Merislon and Myonal in Japan to Kaken Pharmaceutical
March 29 2024 14:51 JST
 
Eisai's Brain Health Self-Check Tool "NouKNOW" is Certified as "ME-BYO BRAND" by Kanagawa Prefecture
March 29 2024 14:19 JST
 
Eisai: Discovery Research on Dual Orexin Receptor Antagonist Lemborexant Honored with PSJ Award for Drug Research and Development 2024
March 29 2024 13:32 JST
 
Lifenet and Eisai Co-Develop Dementia Insurance "be"
March 21 2024 16:36 JST
 
Eisai Selected as a Nadeshiko Brand 2024 as a Listed Company Excelling in Promotion of Women in the Workplace
March 21 2024 15:10 JST
 
Eisai Invests in C2N to Support Simplifying the Diagnosis of Early Alzheimer's Disease to Better Serve Patients
March 06 2024 16:47 JST
 
Eisai to Boost Initiatives on Greenhouse Gas Reduction, Aiming to Achieve Net Zero by 2050
February 21 2024 14:26 JST
 
Eisai Selected for 'Human Capital Leaders 2023' and 'Human Capital Management Gold Quality', Recognized as Company Committed to Excellent Management and Disclosure of Human Capital Initiatives
February 20 2024 08:35 JST
 
Eisai: Metoject Subcutaneous Injection Pen (Methotrexate) Pen-Type Autoinjector Approved in Japan
February 16 2024 08:31 JST
 
Eisai Commences Fully-Fledged Business Activities at Pharma Sales Subsidiary in South Africa
February 01 2024 17:04 JST
 
More Press release >>

Latest Press Release


More Latest Release >>