The trial, targeted to commence in the third quarter of this year, is a 12 month, double blind, placebo-controlled trial and will enroll up to 215 patients with relapsing-remitting multiple sclerosis (RRMS). The trial will be followed by a 15 month active treatment open label extension period.
The primary objective of the study is to demonstrate efficacy and safety of MBP8298 versus placebo in patients who are positive with the immune response genes HLA-DR2 or HLA-DR4 – a patient subgroup which accounts for up to 75% of the MS patient population.
“In addition to our on-going phase III trial for secondary-progressive MS (SPMS), expanding our clinical program into RRMS is significant as the combined patient population for these two indications represent approximately 90% of all MS patients,” said Kevin Giese, president of BioMS Medical.