Positive results for progressive MS drug candidate presented at AAN

Research into the inflammatory nature of MS has led to profound progress in the treatment of the relapsing-remitting form of the disease. But this leaves us with many unanswered questions, and no treatment options, for progressive MS. Progressive MS bears severe consequences, including pronounced disability, cognitive decline, and extreme fatigue. As the need for treatments grows, so too do research efforts to help understand the onset and nature of progressive MS.

Encouraging results from one clinical trial conducted by Paris-based biotechnology company MedDay could pave the way for a novel, promising treatment option for people with progressive MS. The phase III, placebo-controlled clinical trial – dubbed MS-SPI – included 154 participants who were randomly selected to receive either MD1003 (treatment being evaluated) or a mock treatment (control) over a period of one year.

MD1003 is a high-dose formulation (300 mg/day) of biotin. Biotin – or vitamin H – is an FDA-approved food additive and Health Canada-licensed natural health product which, at concentrations of 100 – 300 mg/day, is around 10,000 times higher than the recommended daily intake as a food supplement. The high concentration of biotin in MD1003 has been previously shown to play a role in stimulating myelin production and improving the transmission of signals throughout the nervous system; specifically, it activates several proteins involved in energy production and the synthesis of myelin.

The results of the clinical trial, presented at the AAN conference in Washington D.C., showed that 13% of participants who received MD1003 experienced improvements in disability as determined by changes in EDSS (Expanded Disability Status Scale) or 25-foot walk time, compared to none (0%) of participants who received the mock treatment. Secondary analyses reported a 67% decreased risk of progression in the treatment group, although this finding did not reach statistical significance. It was reported that MD1003 was well tolerated, and that the occurrence of adverse events was similar between the treatment and control groups.

A separate trial called MS-ON is a randomized, double-blind, placebo-controlled phase III clinical trial that is currently underway to investigate visual improvement following treatment with MD1003 in participants affected by visual loss from MS-related optic neuritis. Results from the trial are expected in late 2015.

Categories Research

National vice-president, research, past MS researcher, and PhD in Cellular and Molecular Medicine from University of Ottawa. Leads the MS Society's research program to find the cure for MS and improve the quality of life for people affected by the disease.

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