Mixed results from Phase III studies of LY 2062430 (Eli Lilly) in Alzheimer's Disease patients

Results show that the primary endpoints were not met in either of the two Phase III placebo-controlled EXPEDITION trials of LY 2062430 (solanezumab), from Eli Lilly and Co, in patients with mild-to-moderate Alzheimer's Disease. However, a pre-specified secondary analysis of pooled data across both trials shows statistically significant slowing of cognitive decline in the overall study population.

In addition, secondary subgroup analyses of pooled data 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 (in EXPEDITION1) and angina (in EXPEDITION2).

An ongoing, open-label extension study, EXPEDITION-EXT, is fully enrolled and will continue as planned. An independent analysis of the EXPEDITION studies is being performed by the Alzheimer's Disease Cooperative Study, an academic national research consortium that facilitates the discovery, development and testing of new drugs for the disease. ADCS will present their findings in October. The next steps for the drug have not yet been decided and will be determined after discussions with regulators.