Eli Lilly ($LLY), at work on a huge Alzheimer's disease study with implications for the whole drug industry, is changing the main goal of its trial to reflect what the company called "emerging scientific evidence."
The study, dubbed EXPEDITION3, is testing Lilly's twice-failed solanezumab in about 2,100 patients with early-stage, mild Alzheimer's. The trial was first designed to measure both cognition and physical function as co-primary endpoints, but Lilly has now amended EXPEDITION3 to feature only cognition as its main goal, with function demoted to a secondary endpoint.
"Emerging scientific evidence supports the idea that cognitive decline precedes and predicts functional decline in Alzheimer's disease, particularly in earlier stages of the disease," Lilly said in a statement.
The change doesn't affect how Lilly is handling the global trial, the company said, and investigators will remain blinded to all study data until the trial wraps up in the fourth quarter of this year.
EXPEDITION3 is Lilly's third attempt to prove solanezumab, an antibody therapy, can change the course of Alzheimer's disease. The treatment is part of a class of therapies that target misshapen proteins in the brain called beta amyloids in hopes of slowing the memory-destroying advance of Alzheimer's.
Lilly's antibody managed to effectively reduce amyloid buildups in a pair of Phase III trials back in 2012, but the treatment failed to beat placebo at actually improving cognition and function. Later, poring over the data from those studies, Lilly noted that solanezumab did chart a significant cognitive effect on subjects with mild forms of the disease, and the company designed EXPEDITION3 to focus solely on those patients with the goal of finally winning approval for the treatment.
- read the statement