BioCentury
ARTICLE | Clinical News

Data raise possibility BAN2401 primarily benefits Alzheimer’s subgroup

October 25, 2018 11:09 PM UTC

Eisai Co. Ltd. (Tokyo:4523) and Biogen Inc. (NASDAQ:BIIB) presented detailed data for BAN2401 Thursday that allayed some concerns that the placebo arm had driven a false efficacy signal in the Phase II Study 201 to treat Alzheimer’s disease, but raised concerns that the bulk of the benefit in the active treatment arm may have come from a small subgroup of apolipoprotein E ε 4 (APOE4) carriers who received the highest dose of BAN2401, 10 mg/kg every two weeks.

In data presented at the Clinical Trials on Alzheimer's Disease (CTAD) meeting in Barcelona, Eisai and Biogen said there was no significant difference in cognitive decline between carriers and non-carriers of APOE4 who received placebo. When the companies initially reported 18-month data from the trial in July, they revealed an imbalance in the proportion of APOE4 carriers in the high-dose BAN2401 arm vs. the placebo arm (30% vs. 70%), raising the possibility that the efficacy signal in the trial could have been driven by faster deterioration in the placebo arm rather than treatment with BAN2401...