Solanezumab did not meet the primary endpoint in the EXPEDITION 3 clinical trial to treat moderate Alzheimers disease.- Eli Lilly

Eli Lilly and Company has announced that solanezumab did not meet the primary endpoint in the EXPEDITION 3 clinical trial, a phase III 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).

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. Lilly will work with investigators to appropriately conclude the open-label extensions for EXPEDITION, EXPEDITION 2 and EXPEDITION 3. The next steps for the remaining elements of the solanezumab development program have not yet been determined.

Comment: Other drugs such as bapineuzumab from Pfizer and gantenerumab from Roche have failed as effective therapies for Alzheimers disease and the latest disappointment with solanezumab suggests that the amyloid theory may not lead to resolution of the disease but may only be a link into other brain pathologies.