MedDay High-dose Biotin Fails Clinical Trial

Biotin is an emerging therapy for the treatment of secondary progressive MS.
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MedDay High-dose Biotin Fails Clinical Trial

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Negative Results of High Dose Biotin (MD1003) Clinical Trial Published ... 1003)-Clin

October 29, 2020

A large Phase 3 clinical trial of high-dose Biotin (MD1003®) in people with progressive MS failed to reverse disability or improve walking speed. The results, originally announced by MedDay Pharmaceuticals in March 2020, have now been published. Treatment with biotin led to inaccurate laboratory tests for other health conditions. The authors conclude that MD1003 or commercially available high-dose biotin supplements should not be used to treat progressive MS.

Biotin is considered a form of vitamin B, and is a component of various enzymes that help break down certain substances in the body. It was being tested to see if it could provide support for what may be increased energy demands of brain cells during the course of MS. Previous studies had shown mixed results in people with MS.
This trial involved 642 people with primary progressive MS and secondary progressive MS who did not have recent relapses. Participants took MD1003 or placebo three times a day for 15 months.

The primary endpoint for the study was reversal of functional disability as measured by the proportion of participants with an improvement in either the standard EDSS scale (that largely tests walking ability), or in the time needed to walk 25 feet, at 12 months and confirmed at 15 months. MD1003 did not significantly improve either. Other analyses of nervous system biomarkers also showed no evidence of a neuroprotective effect for biotin.

The US Food and Drug Administration (FDA) has issued Safety Communications about biotin’s interference with lab tests. Misleading laboratory tests could lead to mismanagement of thyroid or cardiac conditions.

”Safety and efficacy of MD1003 (high-dose biotin) in patients with progressive multiple sclerosis (SPI2): a randomised, double-blind, placebo-controlled, phase 3 trial” by Bruce Cree, MD (University of California, San Francisco), Fred Lublin, MD (Icahn School of Medicine at Mount Sinai), and colleagues is published in The Lancet Neurology (Published October 23, 2020).

MD1003 is a registered trademark of MedDay Pharmaceuticals
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