Date: 2017-12-21
Type of
information: DSMB assessment
phase: 2
Announcement: DSMB assessment
Company: Eisai (Japan) Biogen (USA - MA)
Product: BAN2401
Action
mechanism:
- monoclonal antibody. BAN2401 is a humanized monoclonal antibody that is the result of a strategic research alliance between Eisai and the swedish company BioArctic Neuroscience to identify a potential immunotherapy for and other neurological diseases.
- BAN2401 is believed to selectively bind to, neutralize and eliminate soluble, toxic ABeta aggregates that are thought to contribute to the neurodegenerative process in Alzheimer's disease and other neurological diseases. As such, BAN2401 has the potential to have an immunomodulatory effect that may suppress the progression of the disease. Eisai obtained the global rights to study, develop, manufacture and market BAN2401 for the treatment of Alzheimer's disease pursuant to an agreement concluded with BioArctic Neuroscience AB in December 2007. Currently, the compound is undergoing Phase II clinical trials.
- Since March 2014, Eisai and Biogen have been jointly developing BAN2401.
Disease: Alzheimer's disease
Therapeutic
area: Neurodegenerative diseases
Country: Canada, France, Germany, Italy, Japan, Republic of Korea, Netherlands, Spain, Sweden, UK, USA
Trial
details:
- Study 201 is a placebo-controlled, double-blind, parallel-group, randomized study in patients with prodromal or mild Alzheimer’s disease and with positive biomarkers for brain amyloid pathology. The study design included 16 interim analyses that assessed potential for futility or stopping for safety. (NCT01767311)
Latest
news:
- • On December 21, 2017, Eisai and Biogen announced that an Independent Data Monitoring Committee has determined that BAN2401, an anti-amyloid beta protofibril antibody, did not meet the criteria for success based on a Bayesian analysis at 12 months as the primary endpoint in an 856-patient Phase II clinical study (Study 201). Following the predefined study protocol, the blinded study will continue and a comprehensive final analysis will be conducted at 18 months seeking to demonstrate clinically significant results. The results of the final analysis are expected to be obtained during the second half of 2018.
- The study design included 16 interim analyses that assessed potential for futility or stopping for safety. Neither of these conditions was met and the study continues to a full analysis at 18 months. The efficacy of five dose groups of BAN2401 was evaluated at 12 months based on Eisai’s in-house developed novel endpoint Alzheimer’s disease Composite Score (ADCOMS). According to the Bayesian analysis at 12 months, success was judged as an 80% or higher probability of achieving a Clinically Significant Difference (CSD: a 25% or greater reduction in the rate of decline in ADCOMS compared to placebo). In the final analysis at 18 months, a comprehensive evaluation which includes assessing changes from baseline in the clinical evaluation indicators ADCOMS and Clinical Dementia Rating Sum of Boxes (CDR-SB), as well as changes in biomarkers such as brain amyloid levels as measured by amyloid PET and total hippocampal volume using vMRI, will be assessed.
- • In December 2012, Eisai has started a multinational, multicenter, double-blind, placebo-controlled, parallel-group study to determine clinical efficacy and to explore the dose response of BAN2401. BAN2401-G000-201 is an 18-month study in which 3 dose levels (2.5, 5, and 10 mg/kg) are given biweekly (once every 2 weeks) to separate groups of participants and 2 dose levels (5 and 10 mg/kg) are given monthly to separate groups of participants. Participants will be from 2 clinical subgroups: mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild Alzheimer\'s disease dementia. Frequent interim analyses will be conducted to continually update randomization allocation on the basis of the primary clinical endpoint.
Is
general: Yes
