The randomized, double-blind study is enrolling approximately 510 secondary progressive MS patients at approximately 60 sites across the US who will be administered either the peptide, MBP8298, or placebo intravenously every six months for a period of two years.
“This is an important milestone in our strategy to commercialize MBP8298 on a global basis,” said Kevin Giese, president and CEO of BioMS Medical. “The US represents nearly half of the MS market and a successful outcome to this trial would put BioMS in a strong position to capture a significant portion of this and other major MS markets.”
The primary clinical endpoint for the trial is defined as a statistically significant time to disease progression as measured by the Expanded Disability Status Scale, in patients with HLA-DR2 and/or HLA-DR4 immune response genes. Up to 75% of all MS patients are HLA-DR2 and/or HLA-DR4 positive.