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Lilly Announces Detailed Results of Solanezumab Phase 3 EXPEDITION3 Study at CTAD 2016 Meeting; Primary Endpoint was Not Met


Eli Lilly and Company (NYSE: LLY) presented Thursday, detailed results of its phase 3 EXPEDITION3 trial at the 9th Clinical Trials on Alzheimer's Disease (CTAD) meeting. As previously disclosed, solanezumab did not meet the primary endpoint in the EXPEDITION3 clinical trial, a study of solanezumab initiated in people with mild dementia due to Alzheimer's disease (AD), and Lilly will not pursue regulatory submissions for solanezumab for the treatment of mild dementia due to AD.


"The results of EXPEDTION3 are without question disappointing," said Eric Siemers, M.D., distinguished medical fellow at Lilly. "However, Lilly remains committed to finding solutions for this devastating disease. We will continue to analyze study results and work with the external scientific community in the hopes of uncovering findings that will help shape and advance future Alzheimer's disease research."


Lawrence S. Honig, M.D., Ph.D., professor of neurology at Columbia University Medical Center and principal investigator of the EXPEDITION3 study, presented the data at the meeting.


"Alzheimer's is a challenging disease that researchers have been committed to studying for some years," Dr. Honig said. "Now is not the time to give up. While the outcome of this study is not what we had hoped for, it is reasonable to believe that disease modifying therapies to slow down the progression of Alzheimer's disease will be discovered."


A Summary of Key Results
While the study results, including many secondary clinical endpoints, directionally favored solanezumab, the magnitudes of treatment differences were small.


Primary Endpoint

Patients treated with solanezumab did not experience a statistically significant slowing in cognitive decline compared to patients treated with placebo. This finding represented an 11 percent reduction in decline (p=.095), as measured by the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog14) subscale. The ADAS-Cog14 measures a person's cognitive functions, including memory, attention and language abilities.1


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