Eisai’s Bayesian Alzheimer’s Trial Aims For Quick Proof Of Concept With Fewer Subjects, Lower Cost
Executive Summary
Eisai should get the first feedback from an adaptive Phase II trial of BAN2401 in Alzheimer’s patients with mild cognitive impairment in six or seven months, offering the first opportunity to adjust parameters testing dose response and the antibody’s disease-modifying potential or to stop the trial early for futility.
You may also be interested in...
Adaptive Trials Guidance For Pediatric Drugs Will Draw On Device Advice
FDA’s centers may slingshot development work on how best to use control data.
Biogen Hedges Its Bet On Alzheimer’s With Eisai Tie-Up
The big biotech and the Japanese pharma are teaming up to develop four Alzheimer’s treatments in a collaboration that will split development costs and share profits.
Standards For Early Alzheimer’s Drugs Adapted, Not Loosened, FDA’s Katz Says
A draft guidance for development of drugs to treat early Alzheimer’s disease does not loosen agency standards, FDA’s neurology products chief asserts. Rather, it is an attempt to establish criteria tailored to the population.