EDIT: added information about US subsidiary presentation on Alzheimer’s pipeline
Eisai Co said Friday thata 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, who have recently dropped the global Phase 3 trials, ENGAGE and EMERGE, designed to evaluate the efficacy and safety of aducanumab in patients with mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease dementia.
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.
US Eisai subsidiary tp present Alzheimer’s pipeline in Portugal
Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., announces today that seven poster presentations from its Alzheimer’s disease/dementia pipeline will be highlighted at the 14th International Conference on Alzheimer’s & Parkinson’s Diseases (AD/PD) on March 26-31 in Lisbon, Portugal.
“Our data at this year’s AD/PD conference highlights the steady progress we are making with our pipeline as well as our strong commitment to Alzheimer’s disease and dementia,” said Ivan Cheung, Chairman & CEO, Eisai Inc. “We are relentless in our pursuit of scientific innovation to help address the devastation so many patients and families experience living with these debilitating diseases.”