Biotin for Progressive Multiple Sclerosis: New Phase 3 Trial Data
MedDay announced results from its Phase 3 MS-SPI clinical trial with MD1003 (highly concentrated pharmaceutical-grade biotin) for the treatment of progressive multiple sclerosis.
MS-SPI is a randomized, double-blind, multicenter, placebo-controlled trial of MD1003 300mg/day, in patients with progressive MS who have demonstrated progression in the two years prior to enrollment. A total of 154 patients with a baseline Expanded Disability Status Scale (EDSS) score of 4.5–7 were enrolled. Treatment duration was one year. The primary endpoint for the study was defined as the proportion of patients who improved at nine months, with confirmation at 12 months. The primary endpoint for this trial was met.
MD1003 is an investigational medicine thought to have both pro-myelinotic effects and to enhance the supply of energy for nerve impulse transmission. It works by potentially influencing two targets related to progressive MS: (1) it activates acetyl-CoA carboxylases (ACC1 and ACC2), and (2) it activates the Krebs cycle in demyelinated axons to increase energy production.
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