Two Progressive MS Phase III Trials to be Presented at AAN Annual Meeting

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biotinMyelin — the fatty substance that wraps around nerve cells — is lost in multiple sclerosis (MS). Is there any way to get it back or to stop the deterioration of myelin? Researchers at MedDay Pharmaceuticals think that their drug may provide the solution. Known as MD1003, the medication targets the process of forming myelin, called myelination. It may stop the disease from progressing.

MedDay has announced that data from the first pivotal Phase III study using MD1003, a highly-concentrated pharmaceutical-grade biotin for use in primary and secondary progressive multiple sclerosis, will be presented at the Clinical Trials Plenary Session at The American Academy of Neurology (AAN) Annual Meeting, Washington DC on Friday April 24th at 1200 EST.

Two multi-center double-blind placebo-controlled trials in progressive MS examining the effects of MD1003 will be featured. The studies have been ongoing in France and the UK. Researchers completed the first pivotal Phase III study in 150 patients in early 2015. The second study should be finished by the end of the year.

Full session details and data presentation listings for the 2015 Annual Meeting can be found through the AAN website.

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The D-biotin used in MD1003 is actually an FDA-approved food additive. The daily dosage of MD 1003 is approximately 10,000 times greater than the recommended daily dose of D-biotin. Biotin is also called vitamin H, and is a component of B vitamins. Biotin helps the body metabolize fats and carbohydrates, but may also play a crucial role in maintaining nervous system function.

In nerve cells that have lost myelin, MD1003 may increase energy production by activating what is known as the krebs cycle. It could also activate enzymes that help to increase the production of new myelin.

In a pilot study of 23 people with primary and secondary progressive MS, up to 90% of the participants showed clinical improvement over time. This provides hope that the treatment will be successful, but larger studies are needed both to assure that MD1003 is effective, and for regulatory approval. Following positive Phase III clinical trials the medication may be made available for prescribing and use by people with MS.

Scientists are also studying MD1003 for use in a rare neurodegenerative disorder called X-linked adrenoleukodystrophy.

MedDay is a biotechnology company based in Paris, France that develops new drugs for nervous system disorders. Frédéric Sedel, MD, PhD (Chief Executive Officer), a leading neurologist and neuroscientist started MedDay in 2011 along with Guillaume Brion, MD (Chief Operating Officer).

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  1. rmd929 says:

    As someone with PPMS and allodynia, what needs to be done to get this to market as quickly as possible? PPMS is bad enough; the allodynia is, well, indescribable.

  2. ian mackay says:

    I have heard it all before my wife has had spms for 20 years.
    the spasms’ loss of feeling .the road is long.
    if the drug works get it out there

    • wayne fenton says:

      Have spms now , my sentiments exactly get the damned drug out to people NOW they research the shit out of it then pull it away fro you ,how long is this going to go on?

  3. Patricia Browne says:

    I’m sorry but I am disgusted with the whole way MS is treated in the U.S. Comprehensive MS centers? What does that mean? MS Society? All they want is money. They have info on their site that hasn’t been updated for years or is just plain redundant. Many many drug advertising though. There are all kinds of drugs out claiming they can help or reverse symptoms or damage. I don’t believe it. Self help meetings? Try to find one. I feel like I’m just floundering in a MS world of nothingness. Sorry but that is how I feel.

  4. Patricia Browne says:

    It’s all a farce in my opinion. I’ve been to 5 MS comprhensive centers I still don’t know what they mean comprehensive. The MS Society? All information about the disease is redundant & mostly not updated. All they ask for is money. Everyday they say another drug can relieve symptoms or reverse MS. I feel like I am floundering in a world of MS nothingness that does not help us comprehensivly.

  5. Pingback: Researchers Show Neuroprotective Effects of Lanthionine Ketimine Ester – Multiple Sclerosis News Today | Multiple Sclerosis
  6. fran says:

    MedDay, great news we have a few drugs for progressive MS . When could these drug be available? Please we are desperate and need a cure yesterday. Please someone fda or European fda lets make something happen please. Our lives are melting away we need to live too. Thank you.

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