Phase 3 Study of High-Dose Biotin, MD1003, in Treating Primary and Secondary MS Patients Underway

Phase 3 Study of High-Dose Biotin, MD1003, in Treating Primary and Secondary MS Patients Underway

A Phase 3 clinical trial has been launched by MedDay Pharmaceuticals to investigate whether treatment with high-dose biotin (MD1003) may ease disability and improve mobility in non-relapsing primary or secondary progressive MS patients. The study is recruiting participants across the U.S., Canada and Europe.

Biotin is a form of vitamin B, and it plays an important role in energy production within cells. Researchers believe the compound has no anti-inflammatory action, and thus no effect on relapses, but that it treats disability by tackling neuronal loss.

Eligible patients must be 18 to 65 years old, and can maintain existing disease-modifying therapies, if treatment has been stable for at least three months before enrollment. A list of U.S. cities with testing sites can be viewed here.

This randomized and double-blinded trial, called SPI2 (NCT02936037), is expected to enroll 600 MS patients, especially those with gait impairment, who will be assigned to receive either a capsule of MD1003 (100 mg) or a placebo three times a day for 15 months. Results are expected to be known by mid-2019.

MORE: Read “Learning to Push Back Against My Relapsing MS” [Sponsored Post]

“An interesting point with biotin is that it doesn’t seem to work in the short term,” Frédéric Sedel, MedDay’s CEO and co-founder, said in a recent interview with Multiple Sclerosis Today. “When we start the drug, we start to see an effect after at least nine months of treatment.”

Following  the trial’s randomization phase, patients will be allowed to enter an open-label extension study in which all will receive treatment with MD1003 (100 mg) for an additional 12 months.

The study’s main objective is to assess improvements in mobility and changes in disability, as measured on the Expanded Disability Status Scale (EDSS) or a timed test of walking 25 feet. Researchers will also analyze other clinical parameters, such as cognitive function, quality of life, and disease activity as captured on magnetic resonance imaging (MRI) scans.

Results of an earlier Phase 3 clinical trial (NCT02220933) of MD1003 in 154 patients with primary or secondary progressive MS in France, published in the Multiple Sclerosis Journal in 2016, found eased disability progression and improved mobility in 12.6 percent of treated patients, compared to those taking a placebo. The treatment was well-tolerated and no serious side effects were reported.

“What we observed in patients was progressive improvement, which was very unusual, as you know — patients with progressive MS, as with other neurodegenerative diseases, are not supposed to really improve,” Sedel said in the interview.

About 5,000 MS patients in France are also taking MD1003 outside of the earlier and ongoing clinical study, under a temporary license, known as an ATU, granted the treatment by French regulatory authorities, Sedel said.

More information about the newly starting Phase 3 trial is available on its clinical trials.gov webpage.

7 comments

  1. Sheri Goggin says:

    I wish anyone could address my concern that in the pilot study, those in the treatment group showed more new lesions. The pilot even comments that this potential adverse effect should be further analyzed. Docs are now already prescribing this with seemingly no knowledge that there may be a risk. Any info on this anywhere?

    • Tim Bossie says:

      Thank you for the comment Sheri. This is not something we have heard, but will look into it. We do know that many doctors prescribe biotin as it is already available over the counter and there are several people who have had good success while taking higher doses.

  2. Suzanne Greenbaum says:

    I take Biotin for my eyes. My relative had Macular degeneration, so I heard biotin is helpful.
    Also, how does one get in a study? I’ve had MS for 27 years and not once, except for eye an study at Ohio State University. I’m in the progressive stage.

    • Peter says:

      Why do you want to perticipate a study? There is 50% risk, that you will eat one and half year placebo and your condition will worsen.
      Better buy Biotin on your own and use it by the study protocol. Biotin is relatively cheap, you can have high grade pure Biotin powder with gelatine capsules from e-shop for 20$ per month at maximum.

  3. nataša says:

    I have been taking Biotin since January this year. First three months I was taking 3 times 100mg per day, but now, after an additional consultation with my neurologist, I am taking 300mg twice daily.

    I buy it in powder form that I weigh out myself. The results are very encouraging, my illness is not progressing at all, and I feel stronger physically. Because my almost sole problem is walking, I use a walking aid at home and a wheelchair outside. My goal is to be able to walk again. On top of biotin I am also taking 50mg of Baclofen, 12mg of Tizanidine and Fampyra 2x10mg daily. I also take 1000 i.e. of vitamin D and 1 Omega3 fish oil capsule daily.

    I would like to know whether you would have any additional counsel or possible recommendations for me.

  4. Linda says:

    Vitamin D level is too low, try 5000IU per day in addition to 1000mcg B12
    See Professor Jenlinks research and Terry Wahl

  5. Liesbeth Ritzen says:

    Can you give me the address from the E-shop selling the high dose biotin. I live in the Netherlands and the biotin isn”t available so I have to buy it myself.

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