INDIANAPOLIS, Nov. 24 (UPI) -- Solanezumab, a promising experimental drug to treat Alzheimer's disease, failed in large trials, the Eli Lilly pharmaceutical company said.
"Patients treated with solanezumab did not experience a statistically significant slowing in cognitive decline compared to patients treated with placebo...while the study results, including many secondary clinical endpoints, directionally favored solanezumab, the magnitudes of treatment differences were small. There were no new safety signals identified in the study. Lilly will not pursue regulatory submissions for solanezumab for the treatment of mild dementia due to Alzheimer's disease," a statement from Indianapolis-based Eli Lilly and Company said Wednesday.
The failure of the new drug suggests that by the time mild dementia is noticed in a patient, it may be too late to reverse Alzheimer's. The drug was meant to attack amyloid plaque buildup in the brain, the indicator of Alzheimer's.
The disappointing trial results also will renew questions regarding the theory that discovery of the plaque is actually a signal of the disease, the New York Times reported Wednesday.
"The results of the solanezumab Expedition 3 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," said John C. Lechleiter, Lilly president and CEO. "We will evaluate the impact of these results on the development plans for solanezumab and our other Alzheimer's pipeline assets."
No drug has been developed thus far to remove or prevent the amyloid buildup, and other clinical trials of similar drugs continue by other pharmaceutical companies, but Wednesday's announcement is seen as a disappointment.
Solanezumab is "not going to be disease-modifying therapy for mild [Alzheimer's] patients, so that's heartbreaking," said Dave Ricks, the incoming Lilly CEO.