Lilly provides details for new solanezumab trial
Eli Lilly and Co. (NYSE:LLY) unveiled details on Friday of a Phase III trial the pharma plans to start this quarter to evaluate IV solanezumab in 2,100 patients with mild Alzheimer's disease. EXPEDITION3 will be an 18-month, double-blind, placebo-controlled, international trial that will enroll patients who have tested positive for amyloid pathology on a PET or CSF result. The co-primary endpoints will measure the effect of solanezumab on cognitive and functional declines. Lilly said it expects to complete enrollment in the trial by the end of 2016. The pharma declined to disclose how much it expects the trial will cost.
In December, Lilly said it would conduct EXPEDITION3 in only mild AD patients, but the pharma did not provide details. The decision was based on subgroup analysis of pooled data from the Phase III EXPEDITION1 and EXPEDITION2 trials showing solanezumab led to significant reductions in cognitive decline and functional decline compared to placebo in mild AD patients (see BioCentury Extra, Dec. 12, 2012). ...