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ARTICLE | Clinical News

Researchers report solanezumab biomarker data

November 1, 2012 1:34 AM UTC

Researchers at the University of California, San Francisco said an independent analysis of pooled data from the Phase III EXPEDITION1 and EXPEDITION2 trials to treat mild to moderate Alzheimer's disease (AD) showed that IV solanezumab from Eli Lilly and Co. (NYSE:LLY) non-significantly reduced blood levels of beta amyloid in patients with mild AD. The researchers said that the biomarker results suggest that solanezumab's cognitive benefit may be related to the removal of soluble amyloid from the brain into the blood. However, the researchers noted that solanezumab produced no changes in other AD biomarkers, including tau, phosphorylated tau, hippocampal volume, whole brain volume or amyloid accumulation as measured by PET imaging. The Alzheimer's Disease Cooperative Study consortium presented the data at the Clinical Trials on Alzheimer's Disease (CTAD) meeting in Monte Carlo.

Eli Lilly declined to comment on the independent analysis. The pharma said it plans to meet with regulatory authorities to discuss solanezumab, but did not disclose a timeline or next steps. Earlier this month, the pharma reported additional pooled data from the EXPEDITION trials showing that solanezumab led to a significant 34% reduction in cognitive decline vs. placebo in patients with mild AD (see BioCentury Extra, Oct. 8). ...