mercredi 7 octobre 2015
MedDay reports additional positive analyses of its pivotal study with MD1003 in patients with primary and secondary Progressive Multiple Sclerosis
Paris, France, 7 October 2015 - MedDay, a biotechnology company focused on the treatment of nervous system disorders, announces that, during the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain, Prof A. Tourbah, the Principal Investigator of the Phase 3 MS-SPI study, will present a subgroup analysis.
The presentation will occur during the “late breaking news” session on Saturday 10th October 2015 at 09:47 CEST.
The MS-SPI double-blinded placebo-controlled trial with MD1003 was conducted by MedDay in 154 patients in France suffering from primary progressive multiple sclerosis or secondary progressive multiple sclerosis. Positive data showing that the study had met its primary endpoint and main secondary endpoints were announced at the American Academy of Neurology Annual Meeting (AAN) in April 2015 and at the European Academy of Neurology in June 2015.
About the MS-SPI study:
MS-SPI is a randomized 2:1, double-blinded, placebo-controlled study conducted in 16 MS reference centres in France. Treatment duration was one year followed by a one year extension phase during which all patients are taking MD1003.
The patient population was defined as patients suffering from primary progressive Multiple Sclerosis (PPMS) or secondary progressive Multiple Sclerosis (SPMS) with EDSS progression in the two years prior to inclusion and with EDSS ranging from 4.5 to 7. Patients with evidence of relapse or Gadolinium-MRI activity within the past year were excluded from the study.
The primary endpoint of the study was defined as the proportion of patients who improved at 9 months (M9), with a confirmation of the improvement at 12 months (M12). Improvement was defined as either a decrease in EDSS (by at least 1 point for baseline EDSS ≤5.5 and 0.5 points for EDSS ≥6) or an improvement in TW25 (a timed 25-foot walk) of at least 20%. The comparison for each outcome was the best EDSS and TW25 scores obtained at the screening and randomisation visits.
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 has patent protection in EU and US 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.
MD1003’s proof of concept was obtained in a pilot open label study1 involving 23 subjects with primary and secondary progressive MS. Results were positive with up to 90% of subjects exhibiting some clinical improvement over time. Treatment efficacy was also assessed using electrophysiology studies and magnetic resonance spectroscopy.
About progressive MS
MS is the most common disabling neurological disease among young adults, with first symptoms typically manifesting between 20 and 40 years of age. In the majority (85%) of cases, patients experience an initial phase of relapsing-remitting neurological dysfunction (RRMS), which typically evolves into a secondary progressive disease at a later point in the clinical course (SPMS). Once MS is in the progressive phase, individuals experience a gradual worsening of neurological disability leading to problems with vision, walking, incontinence, cognitive changes, fatigue, and pain. Primary progressive MS (PPMS) characterized by disease progression from onset is less common, affecting 10–15% of patients.
Despite these different initial clinical phenotypes, the time to reach certain disability milestones and the ages at which the milestones are reached are similar for patients with PPMS and SPMS. Recent guidelines have therefore proposed to group PPMS and SPMS within a single entity called “progressive disease”. The overall prevalence of patients with progressive disease is estimated to be at least 40% of all MS patients.
Scientific Advisory Board
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); and Guillaume Brion, MD (Chief Operating Officer). 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.medday-pharma.com.
1Sedel, et al. Mult Scler Relat Disord. 2015 Mar;4(2):159-69
For more information, please contact:
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