Nov. 23, 2016
Eli Lilly and Company has announced that solanezumab did not meet the primary endpoint in the EXPEDITION3 clinical trial. This is a phase 3 study of solanezumab in people with mild dementia due to Alzheimer’s disease (AD). Patients treated with solanezumab did not experience a statistically significant slowing in cognitive decline compared to patients treated with placebo (p=.095), as measured by the ADAS-Cog14 (Alzheimer’s Disease Assessment Scale-Cognitive subscale). No new safety signals were identified in the study. Lilly has decided not to pursue regulatory submissions for solanezumab for the treatment of mild dementia due to Alzheimer’s disease.
John C. Lechleiter, Ph.D., chairman, president and chief executive officer, Lilly, said: “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. We will evaluate the impact of these results on the development plans for solanezumab and our other Alzheimer’s pipeline assets.”
“Lilly is grateful for the dedication of the patients, their families, and the clinical investigators who participated in this study. Lilly remains committed to Alzheimer’s research as we have been for nearly 30 years, and our portfolio includes many other promising approaches,” said Jan Lundberg, Ph.D., executive vice president of science and technology and president of Lilly Research Laboratories.