Eli Lilly and Company Announces Top-Line Results on Solanezumab Phase 3 Clinical Trials in Patients with Alzheimer's Disease
Adverse events with an incidence of at least 1 percent that occurred statistically significantly more in the solanezumab group than in the placebo group were lethargy, rash and malaise (in EXPEDITION1) and angina (in EXPEDITION2).
An ongoing, open-label extension study, EXPEDITION-EXT, is fully enrolled and will continue as planned.
"We recognize that the solanezumab studies did not meet their primary endpoints, but we are encouraged by the pooled data that appear to show a slowing of cognitive decline," said
"Lilly is committed to finding medicines that alter the underlying pathology of Alzheimer's disease for the benefit of patients and their loved ones," said
An independent analysis of the data from the EXPEDITION studies is being performed by the Alzheimer's Disease Cooperative Study (ADCS), an academic national research consortium that facilitates the discovery, development and testing of new drugs for the treatment of Alzheimer's disease. ADCS will present their findings at the
The next steps for solanezumab have not yet been decided and will be determined after discussions with regulators.
About the clinical trial endpoints for the EXPEDITION studies
The EXPEDITION1 study did not meet co-primary cognitive and functional endpoints in the overall mild-to-moderate patient population; however, pre-specified secondary subgroup analyses in patients with mild Alzheimer's disease showed a statistically significant reduction in cognitive decline. Based on those results, Lilly modified the statistical analysis plan (SAP) for EXPEDITION2 prior to database lock to specify a single primary endpoint of cognition in the mild patient population. This revised primary endpoint did not achieve statistical significance. In both of the EXPEDITION study protocols, mild Alzheimer's disease was defined as a baseline Mini-Mental Status Examination (MMSE) score of 20 to 26 and moderate Alzheimer's disease was defined as a baseline MMSE score of 16 to 19.
About solanezumab and the EXPEDITION studies
Solanezumab is a monoclonal antibody being studied as a potential therapy for Alzheimer's disease.
The two, Phase 3 double-blind, placebo-controlled solanezumab EXPEDITION clinical trials included more than 2,050 patients with mild-to-moderate Alzheimer's disease in 16 countries around the world. The trials were 18-months in duration.
About Alzheimer's disease
Alzheimer's disease, the most common form of dementia, causes progressive decline in memory and other aspects of cognition.(1),(2) Researchers do not know exactly what causes Alzheimer's disease and there are currently no approved treatments shown to slow the progression of this devastating disease, only treatment options that reduce certain symptoms of the disease.(1),(2),(3) Alzheimer's
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in
This press release contains certain forward-looking statements about solanezumab. This release reflects Lilly's current beliefs; however, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date, or that solanezumab will be approved as a product or will prove to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the
(2) Alzheimer's Association. "2012 Alzheimer's Disease Facts and Figures." Available at: http://www.alz.org/downloads/facts_figures_2012.pdf. Accessed on
(3) Perrin, R., et al. "Multimodal techniques for diagnosis and prognosis of Alzheimer's disease." Nature 2009 (461); 916-922.
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