11 July 2018 - - Tokyo, Japan-based global research and development-based pharmaceutical company Eisai Co., Ltd. and Cambridge, Massachusetts-based neurological and autoimmune disease therapies specialist Biogen (NASDAQ: BIIB) have released positive topline results from the phase 2 study with BAN2401, an anti-amyloid beta protofibril antibody, in patients with early Alzheimer's disease, the companies said.
Study 201 is a placebo-controlled, double-blind, parallel-group, randomized study in 856 patients with mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's dementia with confirmed amyloid pathology in the brain at the start of the study.
Efficacy was evaluated at 18 months and demonstrated a statistically significant slowing of disease progression on the Alzheimer's disease composite score (ADCOMS) after 18 months of treatment in patients receiving the highest treatment dose of 10 mg/kg twice a month and reduction of amyloid accumulated in the brain as measured by using amyloid positron emission tomography (PET).
Dose-dependent changes from baseline were observed across the PET results and the clinical endpoints.
Further, the highest treatment dose of BAN2401 began to show statistically significant clinical benefit as measured by ADCOMS as early as six months including at 12 months.
Eisai Co. has over 10,000 employees working across its global network of research and development facilities, manufacturing sites, and marketing subsidiaries.
The company strives to deliver innovative products in various therapeutic areas with high unmet medical needs, including neurology and oncology.
Biogen discovers, develops, and delivers therapies for people living with serious neurological and neurodegenerative diseases.
The company has a portfolio of medicines to treat multiple sclerosis and spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer's disease, Parkinson's disease, and amyotrophic lateral sclerosis.