Eli Lilly and Company LLY
today announced that the primary endpoints, both cognitive and functional,
were not met in either of the two Phase 3, double-blind, placebo-controlled
solanezumab EXPEDITION trials in patients with mild-to-moderate Alzheimer's
disease. However, a pre-specified secondary analysis of pooled data across
both trials showed statistically significant slowing of cognitive decline in
the overall study population of patients with mild-to-moderate Alzheimer's
disease. In addition, pre-specified secondary subgroup analyses of pooled data
across both studies showed a statistically significant slowing of cognitive
decline in patients with mild Alzheimer's disease, but not in patients with
moderate Alzheimer's disease.
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