New Directions in MS Research: New Therapeutic Approaches
Biotin is another vitamin being studied in MS, particularly in progressive forms of the condition. In particular, recent and ongoing studies have focused on MD1003, which is a pharmaceutical-grade version of the B-complex vitamin.
In MS-SPI, the first trial of MD1003 in progressive MS, study participants taking the vitamin had a significant sustained improvement in disability. Based on those results, researchers now are conducting a Phase III trial called SP12.90 A total of 660 individuals with either primary- and secondary-progressive MS have been enrolled in the trial, which is fully recruited and underway now.
The study participants have been randomized on a 1:1 basis to receive either MD1003 at 300 mg/day or placebo. The study’s primary endpoint is a composite of a decrease in Expanded Disability Status Scale (EDSS) score and/or improved timed 25-foot walk of 20 percent or more from baseline to Month 12, confirmed at Month 15. The study will also assess changes in brain volume, cognitive measures, quality of life scores, and other metrics. Final results are expected by late 2019.90
While the SP12 study moves toward completion, researchers from a French MS Center recently reported their experience in treating people with progressive MS with 300 mg a day of MD1003.91 From January 2016 to May 2018, the investigators had treated 220 patients with MD1003, and had acquired 12 months’ worth of data on 91 of those individuals.
After one year of treatment with MD1003, 23 percent of patients for whom data were available had experienced improvement in their EDSS score, and a separate 23 percent experienced a 20 percent or greater improvement in the time it took them to walk 25 feet. Eleven percent had experienced a clinically defined relapse or had a gadoliniumenhancing T1 lesion on MRI. The investigators, who reported that MD1003 was welltolerated, concluded that, “This real-world study supports the growing body of evidence that MD1003 is an effective and safe treatment for PMS.”91