Call for another Ph III trial of Alzheimer's candidate aducanumab

An analysis published in the journal Alzheimer's & Dementia, authored by David Knopman, David Jones and Michael Greicius, has stated that a further Phase III trial of the investigational Alzheimer’s drug aducanumab has failed to demonstrate efficacy and should undergo a further Phase III study.

Aducanumab, which is scheduled to be reviewed at a Food and Drug Administration advisory panel meeting on November 6, recently underwent two large Phase III clinical trials - EMERGE and ENGAGE - that were stopped prematurely by the sponsor Biogen (Nasdaq: BIIB) and partner Japan’s Eisai (TYO: 4523). One trial was trending positive while the other showed no benefits from aducanumab. Post hoc analyses led the sponsor to assert that there was a sufficient efficacy signal to justify a new drug application as a treatment for Alzheimer's disease, the authors stated.