Biogen Idec has initiated the phase III clinical programme of BG-12, an oral fumarate in development for relapsing-remitting multiple sclerosis (MS).
The Define (determination of the efficacy and safety of oral fumarate in relapsing-remitting MS) and Confirm (comparator and an oral fumarate in relapsing-remitting MS) studies will include more than 2,000 total patients in North America, Europe and rest of world. These studies have been initiated internationally, and Biogen Idec plans to initiate these studies in the US later this year.
Define and Confirm are two-year, randomised, multi-centre, double-blind, placebo-controlled, dose-comparison studies to determine the safety and efficacy of BG-12 in subjects with relapsing-remitting CONFIRM will also include a glatiramer acetate (Copaxone) reference comparator arm.
Endpoints of both studies include evaluating the effect of BG-12 on measurements of clinical relapse, the progression of disability, and various MRI measures.
"Earlier studies of BG-12 support its potential as an oral therapy for multiple sclerosis. The extensive phase III clinical programme of BG-12 will provide greater understanding of its promise in MS," said Define lead investigator Ralf Gold, MD, Prof and chair of the department of neurology, St Josef-Hospital/Ruhr-University Bochum. "MS is a disease that continues to have an unmet need for safe and effective oral therapeutic options."
"The development of BG-12 furthers Biogen Idec's commitment to advancing the treatment of MS. We have a diverse portfolio of therapeutic candidates and are dedicated to the pursuit of innovative research that will yield multiple options for people living with this devastating disease," said Alfred Sandrock, MD, PhD, senior vice president, Neurology Research and Development, Biogen Idec.