Phase 2 Study of BAN2401 Fails to Meet 12-month Goal; Proceeds to 18-month Analysis

Phase 2 Study of BAN2401 Fails to Meet 12-month Goal; Proceeds to 18-month Analysis
BAN2401, an investigational anti-amyloid beta antibody therapy for Alzheimer’s disease, has failed to reach the primary endpoint of a Phase 2 clinical trial measured after 12 months of therapy. Study 201 will continue following the predefined protocol, where a comprehensive analysis will be performed after an 18-month treatment period. Final results are expected in the second half of 2018. BAN2401 is jointly developed under a collaborative agreement between two pharmaceutical companies, Eisai and Biogen. The Phase 2 trial (NCT01767311) enrolled patients with early Alzheimer’s disease carrying biomarkers of brain amyloid pathology, i.e., with build-up of beta-amyloid plaques as shown by positron emission tomography (PET) or by analyzing patients’ cerebrospinal fluid (CSF). Patients were from two two clinical subgroups — those with Alzheimer’s disease-induced mild cognitive impairment, or those with mild Alzheimer's Disease dementia. Patients were assigned randomly to a placebo, control group or to one of five BAN2401-treatment groups: three of them testing escalating dose groups of BAN2401 – 2.5, 5, and 10 mg/kg taken once every two weeks), or to two-dose groups (5 and 10 mg/kg) given monthly. BAN2401 is administered intravenously. The trial included 16 interim analyses, introduced as a means to assess safety issues. But during the 12-month period none were detected, ensuring the trial’s safety to continue up to 18 months. Researchers determined the effectiveness of BAN2401 by measuring the changes in the Alzheimer’s Disease Composite Score (ADCOMS), a new endpoint developed by Eisai, after 12 m
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