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- Esiai, Biogen's BAN2401 Alzheimer's hope approved for study in China
Esiai, Biogen's BAN2401 Alzheimer's hope approved for study in China
The Alzheimer’s disease drug candidate BAN2401, under co-development by US-based Biogen Inc., (Nasdaq: BIIB) and Eisai Co., Ltd, has won clinical trial approval from the National Medical Products Administration (NMPA) in China. The drug candidate is an anti-amyloid beta (Aβ) protofibril antibody that will be targeted as a treatment for mild cognitive impairment (MCI) due to Alzheimer's disease or mild Alzheimer's dementia.
BAN2401 is a humanized monoclonal antibody for Alzheimer’s disease that is the result of a strategic research alliance between Eisai and BioArctic. BAN2401 selectively binds to neutralize and eliminate soluble, toxic Aβ aggregates that are thought to contribute to the neurodegenerative process in Alzheimer’s disease.
An earlier Phase II trial for BAN2401 was thought to have failed at the 12-month stage (the initial cutoff point). However, its fortunes were revived when positive 18-month data showed that the 10 mg/kg dose led to significant reduction in disease progression at 18 months, and delayed clinical decline by 47%.