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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.
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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.
Source: ACN Newswire