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 diseaseAlzheimer'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 Disease International (ADI) estimates that there are currently 35.6 million people with dementia worldwide, with 7.7 million new cases each year (which implies one new case every four seconds). 5 The number of people affected is estimated to be over 115 million by 2050. 4 Estimates vary, but experts suggest that as many as 5.4 million Americans may have Alzheimer's disease. 3About Eli Lilly and CompanyLilly, 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 Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com. P-LLY 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 United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements. 1 National Institute of Neurological Disorders and Stroke. "Dementia: Hope Through Research." Available at: http://www.ninds.nih.gov/disorders/dementias/detail_dementia.htm#1908919213. Accessed on August 13, 2012. 2 Alzheimer's Association. "2012 Alzheimer's Disease Facts and Figures." Available at: http://www.alz.org/downloads/facts_figures_2012.pdf. Accessed on August 13, 2012. 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. 5 Alzheimer's Disease International. "Dementia Statistics." Available at: http://www.alz.co.uk/research/statistics. Accessed on August 13, 2012. (Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO) SOURCE Eli Lilly and Company