Eli Lilly And Co Announces Results of Phase 3 Solanezumab EXPEDITION Studies

Eli Lilly And Co announced its detailed results for the Phase 3, double-blind, placebo-controlled EXPEDITION studies in patients with mild-to-moderate Alzheimer's disease. This announcement follows the presentation of results from independent analyses of the EXPEDITION study data conducted by the Alzheimer's Disease Cooperative Study (ADCS). Lilly provided the raw data (the full data set collected from the EXPEDITION studies) to the ADCS. The ADCS statisticians then performed independent analyses of these data. The EXPEDITION1 study was designed with co-primary cognitive and functional endpoints (the Alzheimer's Disease Assessment Scale- Cognitive subscale [ADAS-Cog11] and the Alzheimer's Disease Cooperative Study-Activities of Daily Living [ADCS-ADL], respectively) in patients with mild-to-moderate Alzeimer's disease. Lilly's pre-specified secondary analyses showed that results in patients with mild Alzheimer's disease taking solanezumab demonstrated a slowing of cognitive decline compared with placebo (p=.008), as measured by the ADAS- Cog11. Based on the results of EXPEDITION1, Lilly modified the statistical analysis plan (SAP) for EXPEDITION2, prior to database lock, to specify a single primary endpoint of cognition in patients with mild Alzheimer's disease as measured by the ADAS-Cog14, a 14-item scale, which includes three additional items considered relevant for patients with mild Alzheimer's disease.