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Positive topline results from Study 201, a phase 2 study of BAN2401, an investigational Alzheimer Disease (AD) therapy, have been announced by Eisai Co. and Biogen.
Positive topline results from Study 201, a phase 2 study of BAN2401, an investigational Alzheimer Disease (AD) therapy, have been announced by Eisai Co. and Biogen, with the treatment achieving statistically significant results on key efficacy endpoints after an 18-month period.
The anti-amyloid beta protofibril antibody resulted in slowed progression in AD Composite Score (ADCOMS), as well as a reduction of amyloid-positron emission tomography (PET) measured amyloid accumulation in the brain.
“This is the first late-stage anti-amyloid antibody study to successfully achieve statistically significant results at 18 months, further validating the amyloid hypothesis,” said Lynn Kramer, MD, the chief clinical and medical officer in the Neurology Business Group at Eisai, in a statement. “We will discuss these very encouraging results with regulatory authorities to determine the best path forward. We continue to work towards the goal of delivering BAN2401 to patients and healthcare professionals as early as possible.”
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