Amid Alzheon Alzheimer’s setback, PIs see new surrogate endpoint

Alzheon’s amyloid-targeting therapy has missed its efficacy endpoints in a Phase III Alzheimer’s trial, but the study’s PIs believe the molecule produced clinically meaningful benefit in a subgroup of early-stage patients. They argue the therapy’s efficacy is backed by a biomarker that could serve as a new surrogate endpoint.

In a presentation on Tuesday at the annual AD/PD conference in Vienna, Anton Porsteinsson, director of the University of Rochester Alzheimer’s Disease Care, Research and Education Program, said valiltramiprosate (ALZ-801) missed the primary and secondary efficacy endpoints in the Phase III APOLLOE4 study. Yet, Porsteinsson and co-presenters Murali Doraiswamy, a professor of psychiatry and medicine at Duke University School of Medicine, and David Watson, CEO and principal investigator at the Alzheimer’s Research and Treatment Center in Wellington, Fla., believe Alzheon Inc.’s small molecule has value...