Potential Alzheimer's Treatment Falls Short in Phase 3 Trial

DECEMBER 01, 2016
Jennifer Barrett, Assistant Editor

A study that evaluated a phase 3 monoclonal antibody treatment that targeted Alzheimer’s disease, solanezumab (Eli Lilly), did not meet its primary endpoint in the EXPEDITION3 clinical trial, according to a statement from the company.

The study, which included more than 2100 patients,  failed to demonstrate any statistically significant slowing in cognitive decline in the monoclonal antibody group compared to patients treated with a placebo over an 18-month period followed by an open label extension. The results were measured by the ADAS-Cog14 (Alzheimer’s Disease Assessment Scale-Cognitive subscale).

Company officials noted they will not pursue regulatory submission for solanezumab for the treatment of mild dementia due to Alzheimer’s disease.

“The results of the solanezumab EXPEDITION3 trial were not what we had hoped for, and we are disappointed for the millions of people waiting for a potential disease-modifying treatment for Alzheimer’s disease,” John C. Lechleiter, PhD, chairman, president, and chief executive officer of Lilly, said in a press release. “We will evaluate the impact of these results on the development plans for solanezumab and our other Alzheimer’s pipeline assets.”