This was the first of several regularly scheduled reviews by the data safety monitoring board (DSMB) that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial.
The Phase II, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of MBP8298 in patients with relapsing-remitting multiple sclerosis. The 15-month trial is fully enrolled with approximately 215 patients at 24 sites in six countries. The objectives of the study are to demonstrate safety and efficacy of MBP8298 versus placebo as measured by relapse rate, MRI activity and disease progression.