Lilly Provides Update on Next Steps for Solanezumab
Based on recent meetings with the
Independent analyses of the Phase 3 solanezumab EXPEDITION data were conducted by the Alzheimer's Disease Cooperative Study (ADCS), an academic research consortium, and presented at the annual meeting of the
"Based on both the independent analyses by the ADCS, as well as our own," said
"We remain encouraged and excited by the solanezumab data," said
Solanezumab is a Phase 3, monoclonal antibody that binds to soluble monomeric forms of amyloid-beta after it is produced, allowing it to be cleared before it clumps together to form beta-amyloid plaques.
About the EXPEDITION Trials
The EXPEDITION trials consisted of two Phase 3, double-blind, placebo-controlled solanezumab trials in patients with mild-to-moderate Alzheimer's disease in 16 countries around the world. 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.
The designs of EXPEDITION1 and EXPEDITION2 were the same. Patients aged 55 years or older were eligible to enroll in these studies; EXPEDITION1 enrolled 1,012 patients and EXPEDITION2 enrolled 1,040 patients. Patients received either 400mg of solanezumab infused intravenously (IV) or placebo every four weeks for approximately 18 months. Both EXPEDITION trials allowed patients to remain on stable standard of care (defined as their existing treatment regimen) during these studies. More than 85 percent of the patients in these trials were taking an acetycholinesterase inhibitor and / or memantine.
While primary endpoints, both cognitive and functional, were not met in the two Phase 3, double-blind, placebo-controlled solanezumab EXPEDITION trials in patients with mild-to-moderate Alzheimer's disease, a pre-specified secondary analysis of pooled data in patients with mild Alzheimer's disease showed a statistically significant slowing of cognitive decline. This finding represented a 34 percent reduction in decline. Over the 18 months of the EXPEDITION studies, the difference between patients treated with solanezumab versus placebo increased at a relatively constant rate over time.
In the pooled analyses of the EXPEDITION studies, the only adverse event with an incidence of at least 1 percent that occurred statistically significantly more in the solanezumab group than in the placebo group was angina (1.1 percent versus 0.2 percent). The incidence of vasogenic edema (ARIA-E) was approximately 1 percent, occurring in 11 patients treated with solanezumab and 5 patients on placebo, which was not statistically significant.
An ongoing, open-label extension study, EXPEDITION-EXT, is fully enrolled and will continue as planned.
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. 1,3,4 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 Robert P, Ferris S, Gauthier S, Ihl R, Winblad B, Tennigkeit F. Review of Alzheimer's disease Scales: Is There a Need for a New Multi-domain Scale for Therapy Evaluation in Medical Practice?. Alzheimer's Research & Therapy. 2010; 2(24): 1-13.
4 Perrin, R., et al. "Multimodal techniques for diagnosis and prognosis of Alzheimer's disease." Nature 2009 (461); 916-922.
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