The B-complex vitamin has performed well in two trials involving people with MS. A phase III trial is now scheduled.
A chance discovery made by scientists in France is generating some important questions.
Namely, “Can high-dose biotin help treat progressive multiple sclerosis?”
Biotin is one of the B-complex vitamins. It’s also known as vitamin H.
The exact role biotin plays in the progression of multiple sclerosis (MS) is not known, but initial studies show it both benefits myelin and provides energy for neurons.
Both of these benefits can help people with relapsing and progressive MS.
Testing out biotin
MD1003 is an investigational medicine containing 300 milligrams of high-quality biotin.
The initial trial that tested it against MS had only 23 participants, but it showed significant results.
A second, randomized double-blind study was larger, with 154 participants. Again, the high-dose biotin showed success in helping improve, and stop, disability in people with progressive and relapsing MS.
Since there is only one FDA-approved drug for progressive MS (Ocrevus), the search is on for more treatments.
Dr. Jaime Imitola, director of the Progressive MS clinic at The Ohio State University, stresses the importance of understanding the results of a study and what it could mean to someone with MS.
“Take, for example, the variety of success that biotin has shown in studies for multiple sclerosis, but the studies are small, under 300 participants,” he told Healthline. “These studies show great potential and more studies are needed since only a subset of patients seems to respond. We need to know more about these responders.”
Moving into the third phase
MedDay Pharmaceuticals, which ran the first two studies on MD1003, is starting a phase III trial of the drug to test its effectiveness as a treatment for progressive MS.
The study, called SPI2, will involve 600 patients from 65 study centers in the United States and Europe.
“The results of phase III will help show the efficacy of these earlier tests.” Dr. Margaret Burnett, associate professor of neurology at the USC Keck School of Medicine, told Healthline.
The USC facility is one of the study centers.
“Biotin is different than other agents,” Burnett explained. “While other approaches have been designed to work with the immune system, MD1003 is designed to preserve and support the nervous system by protecting its oligodendrocytes and neurons.”
This different approach could provide a way to stop disease progression by addressing the factors that cause it, specifically demyelination and damage to the neurons.
Biotin on store shelves
Biotin is available over the counter, but the dose you get is much smaller than what is being tested – about 10,000 micrograms compared to 300 milligrams.
However, the supplement is still showing enough promise for some neurologists to prescribe biotin for their patients.
Dr. Howard Weiner, professor of neurology at Harvard Medical School recently told doctors at the Race to Erase MS Forum that they recommend 300 milligram of biotin for their MS patients from a compounding pharmacy with the caveat that it is a bit pricey at about $150 per month.
High-dose biotin is considered relatively safe with no downsides. But it can affect blood test results for a few conditions such as thyroid disease and should be stopped prior to blood work.
Biotin is also available naturally through a healthy diet. Humans, or any mammal, cannot synthesize biotin and must obtain it from dietary sources such as eggs, dairy, almonds, whole grains, and meat.
No tests to date have been performed on biotin from food having any effect on MS.
“Nutrition is extremely important,” said Burnett.
She also notes that while there is no one diet recommended for everyone with MS, she “encourages all patients to eat a well-rounded diet.”