The Ministry of Food and Drug Safety has approved the phase 3 clinical trial of Eisai's BAN2401, an Alzheimer's disease treatment candidate, applied by Linical Korea, a contract research organization.
The trial is part of an ongoing placebo-controlled, double-blind, parallel arm, 18-month global phase 3 clinical trial, which will confirm the treatment's efficacy and safety on patients with early Alzheimer's symptoms.
A total of 1,566 patients will participate in the trial globally, including 102 patients from Korea, and hospitals conducting the test include Seoul National University Hospital, Asan Medical Center, Dong-A University Hospital, Inha University Hospital, and Hanyang University Medical Center.
The trial will compare the treatment's efficacy after dividing the patients into two groups -- one receiving a 10 mg/kg injection of BAN2401 twice a week and one receiving a placebo. The primary endpoint will be the change in "Clinical Dementia Rating-Sum of Boxes" after 18 months of treatment.
BAN2401 is an early-onset Alzheimer's treatment drug jointly developed by Eisai and Biogen.
The treatment is a beta-amyloid antibody and has a mechanism of selective binding and neutralization as well as the elimination of beta-amyloid affecting the neurodegenerative process of Alzheimer's disease.
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