INDIANAPOLIS (dpa-AFX) - Eli Lilly and Co. (LLY) noted that the primary endpoints, both cognitive and functional, were not met in either of the two Phase 3, double-blind, placebo-controlled solanezumab EXPEDITION studies in patients with mild-to-moderate Alzheimer's disease. However, a pre-specified secondary analysis of pooled data across both trials demonstrated statistically significant slowing of cognitive decline in the overall study population of patients with mild-to-moderate Alzheimer's disease.
Further, 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.
Adverse events with an incidence of at least 1 percent that occurred statistically significantly more in the solanezumab group than in the placebo group were lethargy, rash and malaise and angina. An ongoing, open-label extension study, EXPEDITION-EXT, is fully enrolled and would continue as planned.
The company has not decided on the next steps for solanezumab and would be determined after talks with regulators.
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