Given the recent controversy (July 2018, AAIC meeting, Chicago) , I thought I’d unearth this comment from last year:
“Eisai and Biogen’s Alzheimer’s drug flunks…”[FierceBiotech 12.21.17]: silver lining?
BAN2401 really is different from Biogen’s aducanumab, but I wasn’t familiar with the assessment used at 12M, ADCOMS. According to the Eisai’s press release, there are “futility” (!) and safety thresholds that were not crossed, allowing it to continue. The release implies that surrogate measures, such as imaging, will be assessed at 18M, so this was really all about cognitive testing (the most important to me, anyway). In my Op-Ed in 2015, among other things I mention are improved measures in trials, and creative trial designs, so this Japanese company Eisai seems to be doing those two. “ADCOMS” is a way to combine certain elements of standard tests that seems to have good discrimination in “prodromal” AD and Mild Cog Impairment; they were very clever in combining datasets and placebo groups from earlier studies, and published ADCOMS in 2016. The statistics are over my head, but it was evidently driven by Eisai, BRAVO! Too bad about their monoclonal, but maybe others can use their trial design as a template. [NIH public domain image: rat hippocampus Deernick]