The investigational new drug application allows the commencement of a phase III multiple sclerosis (MS) trial in the US and has been granted on the basis of satisfying FDA criteria regarding data from the completed and ongoing studies for the drug, MBP8298.
The primary endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease in MS patients with HLA-DR2 or HLA-DR4 immune response genes.
In MS patients, the body’s immune system inappropriately attacks the myelin coating around the nerves in the brain and spinal column, whereas healthy people are otherwise “tolerant” of such common body components. The proposed mechanism of action of MBP8298 is to re-introduce such a state of “tolerance” to a critical portion of the nerve’s myelin basic protein that is an immunological site of attack in many MS patients. This is accomplished by the intravenous injection of MBP8298 every six months.
Phase II and long-term follow-up treatment of MS patients with MBP8298, showed that MBP8298 safely delayed the median time to disease progression for five years in progressive MS patients with HLA-DR2 or HLA-DR4 immune response genes.