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 (RRMS) in the first of several European countries. Patient enrollment is targeted to commence in the third quarter of this year and the company anticipates that up to 30 sites will participate.
The trial is a 12-month, double blind, placebo-controlled trial and will enroll up to 215 RRMS patients. 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 immune response genes HLA-DR2 or HLA-DR4. Patients with the immune response genes, HLA-DR2 or HLA-DR4, account for up to 75 percent of the MS patient population.