Eli Lilly has announced plans to start enrolling patients for two separate but identical Phase III clinical trials of solanezumab(i), a possible treatment to delay the progression of mild-to-moderate Alzheimer's disease.
The trials, termed EXPEDITION and EXPEDITION 2, will test solanezumab(i), an anti-amyloid beta monoclonal antibody using identical multicentre, randomised, double-blind and placebo-controlled trials.
Each trial will include a treatment period that lasts one-and-a-half years and they are expected to enroll a total of 2,000 patients. In combination, the EXPEDITION and IDENTITY trials will include approximately 4,600 patients with Alzheimer's disease.
Eli Lilly medical cirector, Alzheimer's disease research Eric Siemers said that current therapies available to treat Alzheimer's disease may help with symptoms, but hadn't yet been proven to change the disease progression.
"Biomarker results from a Phase II solanezumab trial give us hope that Lilly is on a path toward a treatment that may slow the rate of progression of Alzheimer's disease," he said.
EXPEDITION will be conducted in Argentina, Brazil, Canada, Japan and the US. EXPEDITION 2 will be conducted in Australia, France, Germany, Italy, Japan, Korea, Poland, Russia, Spain, Sweden, Taiwan, the UK and the US.
The primary objective of the trials is to test whether solanezumab will slow the cognitive and functional decline of Alzheimer's disease patients, as compared to placebo. Secondary objectives include different clinical benefits as measured by several brain-scanning and biochemical biomarkers and ratings scales, and quality of life impact.