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news.BioMS Medical has reported positive results from the phase II and long-term follow-up treatment of multiple sclerosis patients with MBP8298, in terms of both long-term efficacy and safety.
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The phase II study followed 32 patients with clinically diagnosed, MRI-confirmed progressive MS for 24 months, comparing safety and efficacy between MBP8298 and placebo administered intravenously every six months.
The results, published in the European Journal of Neurology, show that MBP8298 safely delayed disease progression for five years in progressive multiple sclerosis (MS) patients with HLA-DR2 or HLA-DR4 immune response genes.
Treatment and follow-up of patients demonstrated that patients in this DR2 and DR4 responder group, who comprise up to 75% of MS patients, had a median time to disease progression of 78 months, as compared to 18 months for patients who received placebo.
No serious adverse events were reported during the trial and follow-up period, with MBP8298 appearing to be well tolerated.
“Our data suggest that we can safely delay progression of MS in an identified responder group of patients for extended periods of time,” said Ingrid Catz, co-inventor of MBP8298 and co-author of the phase II study. “The identification of this responder group will improve efficiency toward the achievement of objectives in future clinical trials with MBP8298, while the potential for clinical responses in patients with other HLA haplotypes is further explored.”
“While this is phase II data and needs to be confirmed in the on-going phase III trial, it is very hopeful information for MS patients,” added Dr Mark Freedman, professor of neurology at the University of Ottawa, Canada and director of the Multiple Sclerosis Research Clinic at the Ottawa Hospital. “To delay disease progression for five years in progressive MS patients is a big step – there are currently very limited options available to treat this form of multiple sclerosis.”
BioMS Medical is currently enrolling patients across Canada, the UK, Sweden and Denmark in its pivotal phase II/III clinical trial evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). The trial is a randomized, double-blind study enrolling approximately 553 patients who will be administered either MBP8298 or placebo intravenously every six months for a period of two years.