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B Vitamin Promising in Progressive Multiple Sclerosis

April 30, 2015

A regimen of high doses of biotin, a water-soluble B vitamin, appears to be effective in patients with primary or secondary progressive multiple sclerosis (MS), according to emerging research.

A new phase 3 study of the investigational drug MD1003 (MedDay Pharmaceuticals), a highly concentrated pharmaceutical-grade biotin, found that patients with progressive MS taking the drug had significant improvement at 9 months, which was confirmed at 12 months, compared with those taking placebo.

"We are encouraged that the primary endpoint was met despite the very high bar for treatment response," said the study's principal investigator, Professor Ayman Tourbah, of CHU de Reims, Neurology, France, in a press release. The results, he said, suggest that MD1003 "could be an important and efficacious treatment for primary and secondary progressive multiple sclerosis."

Currently, there are no effective therapies for progressive MS. The results were presented at the Clinical Trials Plenary Session during the American Academy of Neurology (AAN) 67th Annual Meeting and again during a subsequent webcast.

Two Mechanisms

Biotin is a coenzyme for carboxylases, which are enzymes critical in energy metabolism and production of fatty acids. It targets two mechanisms that might be involved in progressive MS: promoting myelination and increasing energy production.

It's hypothesized that biotin may help to slow, stop, or even reverse the progression of disability associated with demyelination.

In his presentation, Dr Tourbah referred to a small uncontrolled "proof of concept" study of 23 patients with progressive MS who were treated with a mean of 300 mg of biotin per day for about 9 months. In this study, 22% of patients had a significant clinical improvement on the Expanded Disability Status Scale (EDSS).

The new study included 154 patients aged 18 to 75 years (mean age, about 51 years) with primary or secondary progressive MS and an EDSS score of 4.5 to 7. During the previous 2 years, they must have had a progression on the EDSS of at least 1 point if their baseline EDSS score was 4.5 to 5.5, and of 0.5 point if their baseline EDSS score was 6 to 7.

Patients were randomly assigned to placebo (n = 51) or to oral MD1003 (n = 103), which is tasteless and colorless. The mean dose of the drug was 300 mg/day. About 41% of the treatment group and 55% of the placebo group were also taking fampridine, a drug used to manage MS symptoms.

Patients were followed for a mean of 9 months and up to 36 months. Twelve patients in the treatment group and eight patients in the placebo group discontinued the study but were included in the intention-to-treat (ITT) analysis.

Main Outcome

The main outcome was improvement at 9 months, and confirmed at 12 months, using either a change in EDSS score of at least 1 point (if baseline EDSS was 4.5 to 5.5) and 0.5 point (if baseline EDSS was 6 to 7) or a decrease in timed 25-foot walk (TW25) of 20% compared to baseline.

In the ITT population, 12.62% of the MD1003 group and 0.0% of the placebo group met this criteria (P = .0051). In the per protocol population, 14.9% of the MD1003 and 0.0% of the placebo group met the primary endpoint (P = .0093).

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