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MD1003 ‘effective’ in Phase III trial (01/06/16)

Data from an extension phase of a Phase III clinical trial claims the biotin MD1003 showed effectiveness over time as a possible treatment of non-active, progressive multiple sclerosis (MS).

The data was presented at the 2nd Congress of the European Academy of Neurology (EAN) in Denmark by Professor Ayman Tourbah, the trial’s principal investigator. MS-SPI, as the clinical trial and its two-year follow-up is known, evaluated MD1003 at a dose of 300mg per day to treat patients with not-active progressive MS.

Participants had to demonstrate disease progression of disability in the previous two years with no evidence of inflammatory activity, and were randomly assigned to receive either MD1003 or a placebo for 12 months.

Results from the extension phase determined sustained efficacy for up to two years and further established a good safety profile for the drug. MD1003 is a highly concentrated form of biotin, a vitamin that activates some enzymes involved in cell growth and myelin production.

The drug, which is already commercially available in certain European countries under early access programs, has previously shown efficacy in patients with progressive MS. It acts by increasing a route of cellular energy production, protecting against the breakdown of nerve cell axons. It also activates enzymes that are setting the pace on myelin repair by being involved in the production of myelin constituents.

Source: Multiple Sclerosis News Today © Copyright 2014 - 2016 BioNews Services, LLC (01/06/16)