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Lilly's solanezumab misses in AD

August 25, 2012 12:04 AM UTC

Eli Lilly and Co. (NYSE:LLY) said IV solanezumab given every four weeks missed the primary endpoints vs. placebo in two Phase III trials to treat Alzheimer's disease. In the EXPEDITION1 trial, solanezumab missed the co-primary endpoints of improving cognitive and functional scores from baseline to week 80 vs. placebo. A pre-specified secondary subgroup analysis showed that solanezumab did significantly improve cognitive scores vs. placebo in patients with mild AD. Based on the data, Lilly modified the statistical analysis plan for EXPEDITION2 to specify a single primary endpoint of cognitive scores from baseline to week 80 in patients with mild AD. However, solanezumab missed that endpoint. The product is an antibody binding to soluble beta amyloid. ...