(By Balachander) Eli Lilly & Co. (NYSE: LLY) announced plans to conduct an additional late-stage study of solanezumab in patients with mild Alzheimer's disease.
The Indianapolis, Indiana-based company said it expects to initiate the Phase 3 study of its experimental Alzheimer's treatment Solanezumab no later than the third quarter of 2013.
Solanezumab failed to meet main objectives of late-stage studies earlier this year, though a pre-specified secondary analysis of pooled data in patients with mild Alzheimer's disease showed a statistically significant slowing of cognitive decline.
Lilly said it will continue to analyze and discuss the data from the two, Phase 3, double-blind, placebo-controlled solanezumab EXPEDITION studies with regulators globally to determine the regulatory paths forward in different regions.
The EXPEDITION trials consisted of two Phase 3, double-blind, placebo-controlled solanezumab trials in patients with mild-to-moderate Alzheimer's disease in 16 countries around the world.
Alzheimer's disease, the most common form of dementia, causes progressive decline in memory and other aspects of cognition.
Alzheimer's Disease International (ADI) estimates that there are currently 35.6 million people with dementia worldwide, with 7.7 million new cases each year.
"Based on both the independent analyses by the ADCS, as well as our own," said Eric Siemers, senior medical director of Lilly's Alzheimer's disease team, "we believe the results demonstrating a slowing of cognitive decline in patients with mild Alzheimer's disease treated with solanezumab are the first data from Phase 3 clinical trials that support the amyloid hypothesis."
LLY shares closed at $50.60 on Tuesday.