Lilly Announces Detailed Results of Solanezumab Phase 3 EXPEDITION3 Study at the Clinical Trials on Alzheimer's Disease (CTAD) 2016 Meeting

INDIANAPOLIS, Dec. 8, 2016 /CNW/ -- Eli Lilly and Company (NYSE:LLY) today presented 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

Key Secondary Clinical Endpoints
As the primary endpoint was not met in this study, the p-values for the efficacy secondary statistical analyses were not adjusted for multiple comparisons.

Biomarkers

Changes in plasma a-beta were similar to those seen in previous studies, and the differences between treatment and placebo groups were statistically significant. Changes in amyloid deposition as measured by positron emission tomography (PET) imaging did not reach statistical significance between treatment and placebo groups.

Adverse events

About Solanezumab

Solanezumab is Lilly's phase 3 monoclonal antibody being studied as a potential therapy for people with mild cognitive impairment due to Alzheimer's disease (EXPEDITION-PRO), preclinical Alzheimer's disease (Anti-Amyloid Treatment in Asymptomatic Alzheimer's "A4"), and Dominantly Inherited Alzheimer's Disease ("DIAN").

About EXPEDITION3

EXPEDITION3 is a multinational, phase 3 trial of solanezumab in more than 2,100 patients diagnosed with mild dementia due to Alzheimer's disease. The study includes an 18-month placebo-controlled period followed by an open label extension. Enrollment was completed in 2015 and the last patient visit for the placebo-controlled period occurred in October 2016. EXPEDITION3 is the first phase 3 trial to evaluate only people with mild dementia due to Alzheimer's disease.

About Alzheimer's Disease

Alzheimer's disease is a fatal illness that is believed to start with changes in the brain that may begin 20 years or more before symptoms appear.[6] Those changes cause a progressive decline in memory and other aspects of cognition that eventually lead to dementia.

Dementia due to Alzheimer's disease is the most common form of dementia, accounting for 60 to 80 percent of dementia cases.6 There are currently an estimated 47 million people living with dementia worldwide.7 The number of people affected by dementia is expected to be nearly 75 million in 2030 and 131 million in 2050.7 Estimates vary, but experts suggest that as many as 5.4 million Americans may have Alzheimer's disease.6 

About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels. P-LLY

This press release contains certain forward-looking statements about solanezumab, an anti-amyloid monoclonal antibody in clinical testing for treatment of Alzheimer's disease, and reflects Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there is no guarantee that future study results and patient experience will be consistent with study findings to date or that solanezumab will receive regulatory approvals or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

1 Liu-Seifert H., et al. Cognitive and Functional Decline and Their Relationship in Patients with Mild Alzheimer's Dementia. Journal of Alzheimer's Disease. 43 (2015) 949-955
2 Alzheimer's Society. The Mini Mental State Examination. https://www.alzheimers.org.uk/site/scripts/documents_info.php?documentID=121. Accessed November 2016
3 The Washington University Knight ADRC. http://alzheimer.wustl.edu/CDR/CDR.htm. Accessed November 2016.
4 Liu-Seifert H., et al. Cognitive and Functional Decline and Their Relationship in Patients with Mild Alzheimer's Dementia. Journal of Alzheimer's Disease. 43 (2015) 949-955
5 Alzheimer's Association. Tools for Early Identification, Assessment, and Treatment for People with Alzheimer's Disease and Dementia. https://www.alz.org/national/documents/brochure_toolsforidassesstreat.pdf. Accessed November 2016.
6 Alzheimer's Association. 2016 Alzheimer's Disease Facts and Figures. http://www.alz.org/documents_custom/2016-facts-and-figures.pdf. Accessed November 2016.
7 Alzheimer's Disease International. Dementia statistics. http://www.alz.co.uk/research/statistics. Accessed November 2016.

Refer to:  Media - Nicole Hebert; hebert_nicole@lilly.com; 317.701.9984
Investors - Phil Johnson; johnson_philip_l@lilly.com; 317.655.6874

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