Our Discovery Development Story

  • MD1003 is an investigational medicine thought to have both pro-myelinogenic effects and to enhance the supply of energy for nerve impulse transmission. MD1003 is an active pharmaceutical ingredient administered at a dose of 300 mg /day. It has patent protection in EU (Use of biotin for the treatment of multiple sclerosis: EP 2729143 B1) and US (Method of treating multiple sclerosis: US 8835487 B2) for dose and use in multiple sclerosis. MD1003 has a mode of action which potentially influences two targets related to progressive MS: (1) it activates acetyl-CoA carboxylases (ACC1 and ACC2), the rate-limiting enzymes in the synthesis of fatty acids required for myelin synthesis, and (2) it activates the Krebs cycle in demyelinated axons to increase energy production. 

  • The results from two phase 2b/3, placebo-controlled, pivotal studies, involving 250 patients and 21 MS reference centers in France and the UK (ClinicalTrials.gov Identifiers: NCT02220933 and NCT02220244) have been announced. The results of the principal analysis of the MS-SPI study (ClinicalTrials.gov Identifier NCT02220933) were presented at the American Academy of Neurology on April 24th 2015 (see press release for more details). The results from the second placebo-controlled study, the MS-ON study (ClinicalTrials.gov Identifier: NCT02220244) were announced in December 2015 (see press release for more details).

  • MedDay works closely with all stakeholders to ensure optimisation of the drug development and regulatory pathway.

  • Pharmacokinetic studies in healthy volunteers, animal toxicology studies and non-clinical proof of concept studies have being performed.

  • In addition, a phase 2b/3 clinical study has started in the adult form of X-linked adrenoleukodystrophy. This clinical trial is funded by the European Leukodystrophy Association (ELA) and involves four reference centers in France, Germany and Spain.

  • In European territories, MedDay works with Medical Need Europe (www.medicalneed.com).

  • MedDay has recently started a large-scale clinical trial, known as MS-SPI 2, investigating MD1003 for the treatment of not-active progressive multiple sclerosis. The trial plans to enrol 600 patients at approximately 65 study centers in the US and Europe. For more information on the study visit http://spi2study.com

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