Two Progressive MS Phase III Trials to be Presented at AAN Annual Meeting
Myelin — 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.
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).