Eli Lilly's Phase 3 solanezumab clinical trial did not meet primary endpoint
Eli Lilly announced that solanezumab did not meet the primary endpoint in the EXPEDITION3 clinical trial, a phase 3 study of solanezumab in people with mild dementia due to Alzheimer's disease. Patients treated with solanezumab did not experience a statistically significant slowing in cognitive decline compared to patients treated with placebo, as measured by the ADAS-Cog14. 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, EXPEDITION2 and EXPEDITION3. The EXPEDITION3 study outcome is expected to result in a Q4 charge of approximately $150M pre-tax, or approximately 9c per share after-tax.