Download MedDay to present Pivotal Phase III data in Progressive Multiple

MedDay to present Pivotal Phase III data in Progressive Multiple Sclerosis at AAN
Annual Meeting
Paris, March 4 2015 - MedDay, a biotechnology company focused on the treatment of nervous system
disorders, today announces that data from its first pivotal Phase III study with MD1003 (a highlyconcentrated pharmaceutical-grade biotin) for the treatment of 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.
MedDay has been running two multi-centric double-blind placebo-controlled trials in progressive MS
using their lead candidate, MD1003, in France and UK. The first pivotal Phase III study in 150 patients
was completed in Q1 2015. The second pivotal study is on track to be completed by the end of 2015.
Full session details and data presentation listings for the 2015 Annual Meeting can be found through
the AAN website: www.aan.com/conferences/2015-annual-meeting.
-EndsAbout MedDay
MedDay is a privately held biotechnology company developing new drugs for nervous system
disorders. The company was founded in 2011 by Frédéric Sedel, MD, PhD (Chief Executive Officer), a
leading neurologist and neuroscientist; and Guillaume Brion, MD (Chief Operating Officer) who has 25
years of experience in drug development and clinical research in the pharmaceutical industry. In April
2013, InnoBio, a biotechnology fund managed by BPIFrance, and Sofinnova Partners together invested
in MedDay. The Company’s most advanced pipeline candidate is MD1003 for the treatment of primary
and secondary progressive multiple sclerosis. For more information, please see: www.meddaypharma.com.
About MD1003
MD1003 is a highly-concentrated pharmaceutical-grade biotin. The dosage is 300 mg/day
corresponding to 10,000 times the recommended daily intake of biotin. As such, MD1003 is an active
pharmaceutical ingredient and has patent protection in EU and US for dose and use in multiple
sclerosis. Biotin is a key co-factor for enzymes involved in energy production and synthesis of myelin.
Biotin has potentially two targets related to progressive MS: (1) it activates acetyl-CoA carboxylases
(ACC1 and ACC2), the rate-limiting enzymes in the synthesis of long chain fatty acids required for
myelin synthesis, and (2) it activates the Krebs cycle in demyelinated axons to increase energy
production.
MD1003’s proof of concept has been obtained in a pilot open label study involving 23 subjects with
primary and secondary progressive MS. Results were positive with up to 90% of subjects exhibiting
clinical improvement over time. Treatment efficacy was also assessed using electrophysiology studies
and magnetic resonance spectroscopy.
For more information, please contact:
MedDay Pharmaceuticals
Email: [email protected]
Consilium Strategic Communications
Mary-Jane Elliott, Jonathan Birt, Ivar Milligan, Laura Thornton
Tel: +44 (0)20 3709 5700
Email: [email protected]