We talk a lot about the treatment of relapsing-remitting MSM but we really want to develop more treatment options for progressive MS.
Dirucotide (MBP8298) is being studied in clinical trials for the treatment of secondary progressive MS (SPMS) at 68 sites with approximately 510 patients. The FDA has given fast track status because of the potential to do good for people with SPMS as it has the potential to address unmet medical needs. Fast track designation can potentially facilitate development and expedite the review process.
The company doing the trials is so excited that they said: “Based on previous clinical results, we believe dirucotide is well-positioned to become a first-in-class treatment for secondary progressive MS patients, a large patient population with very limited treatment options.”
The trial is called MAESTRO-03 and is a phase III clinical trial. It is a randomized, double-blind study that has completed recruitment of approximately 510 patients at 68 clinical sites who will be administered either dirucotide (MBP8298) or placebo intravenously every six months for a period of two years.
The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), 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).
Patients are first tested for this gene. Remember though, that this is not a genetic test for MS. A lot of people without MS have this too.
Dirucotide (MBP8298) is a synthetic peptide (protein) that consists of 17 amino acids (building blocks of proteins) having a sequence identical to that of a portion of human myelin basic protein (MBP). The way the drug seems to work is that it makes the immune system tolerant to the protein because of high doses of peptide periodically delivered intravenously. The potential benefit of the drug for any individual patient is therefore expected to be related to the role this peptide plays in that patient’s immune system.
This is exciting for the MS community because of the potential to treat progressive forms of MS.
Published On: September 23, 2008