Solanezumab ineffective for cognition in Alzheimer’s disease

Eli Lilly recently announced that solanezumab did not achieve a statistically significant reduction in cognitive decline among individuals with 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 CEO of Eli 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.”

Researchers conducted a phase 3 trial of solanezumab among 2,100 individuals with mild dementia due to Alzheimer’s disease. Study participants underwent an 18-month placebo-controlled trial followed by an open label extension.

Participants who received solanezumab did not exhibit statistically significant slowing in cognitive decline indicated by Alzheimer’s Disease Assessment Scale-Cognitive subscale scores, compared with participants who received placebo (P = .095).

Study findings favored solanezumab, according to researchers, but treatment differences were small.

Findings did not indicate new safety signals for solanezumab.

As a result, Eli Lilly will not pursue regulatory submissions for solanezumab for mild dementia due to Alzheimer’s disease, according to the release.

The company plans to work with researchers to appropriately conclude the open-label extensions of EXPEDITION, EXPEDITION2 and EXPEDITION3.

“Lilly is grateful for the dedication of the patients, their families, and the clinical investigators who participated in this study,” Jan Lundberg, PhD, executive vice president of science and technology and president of Eli Lilly Research Laboratories, said in the release. “Lilly remains committed to Alzheimer's research as we have been for nearly 30 years, and our portfolio includes many other promising approaches.”