BioCentury
ARTICLE | Clinical News

Lilly planning additional solanezumab trial

December 13, 2012 2:25 AM UTC

Eli Lilly and Co. (NYSE:LLY) said it will start by no later than 3Q13 an additional Phase III trial of IV solanezumab, an antibody binding to soluble beta amyloid, in patients with mild Alzheimer's disease. The pharma is still finalizing trial details. Lilly said it made the decision to evaluate the product in only mild AD patients based on subgroup data and an independent analysis of pooled data from the Phase III EXPEDITION1 and EXPEDITION2 trials, which were evaluating solanezumab in mild to moderate AD patients.

In October, Lilly reported subgroup data from the trials showing that mild AD patients receiving solanezumab had a 34% reduction in cognitive decline compared to placebo (p=0.001). Later in the month, a group of independent researchers said that solanezumab non-significantly reduced blood levels of beta amyloid in patients with mild AD, which the researchers said suggest that solanezumab's cognitive benefit may be related to the removal of soluble amyloid from the brain into the blood. The researchers did note that solanezumab produced no changes in other AD biomarkers (see BioCentury Extra, Oct. 31). ...