Eisai, Biogen continuing AD trial of BAN2401 despite 12-month failure
Eisai Co. Ltd. (Tokyo:4523) and Biogen Inc. (NASDAQ:BIIB) said an IDMC determined that BAN2401 "did not meet the criteria for success" at 12 months on the primary endpoint in the Phase II Study 201 to treat prodromal or mild Alzheimer’s disease. The partners said the study will remain blinded and will continue until its final 18-month analysis, from which data are due in 2H18. BAN2401 is a humanized conformational specific IgG1 mAb targeting the toxic beta amyloid protofibrils.
On the 856-patient trial’s primary endpoint of AD Composite Score (ADCOMS), success at 12 months was determined by an 80% or higher probability of achieving a 25% or greater reduction in the rate of decline in ADCOMS per a Bayesian analysis vs. placebo. Despite missing the 12-month success criteria, the companies said BAN2401 did not meet the conditions for futility or stoppage for safety at any of its interim analyses...