BioMS Medical has received regulatory approval to initiate a Phase II human clinical trial to investigate the efficacy and safety of MBP8298 in patients with relapsing-remitting multiple sclerosis (MS) in the first of several European countries.
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 that accounts for up to 75 percent of the MS patient population.