Eli Lilly and Company is going to start enrolling patients for two separate but identical Phase III clinical trials of solanezumab(i), an anti-amyloid beta monoclonal antibody being researched as a possible treatment to delay the progression of mild-to-moderate Alzheimer's disease.
The trials, termed as EXPEDITION and EXPEDITION 2, are identical multicenter, randomized, double-blind and placebo-controlled trials. Each will include a treatment period that lasts one and half year and 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.
EXPEDITION will be conducted in Argentina, Brazil, Canada, Japan, and US. EXPEDITION 2 will be conducted in Australia, France, Germany, Italy, Japan, Korea, Poland, Russia, Spain, Sweden, Taiwan, UK and US.
The primary objective of both 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.
Eric Siemers, Medical Director, Alzheimer’s disease research for Eli Lilly and Company, said: “current therapies available to treat Alzheimer’s disease may help with symptoms, but they haven’t 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.”