Paris, France, April 24 2015 - MedDay, a biotechnology company focused on the treatment of nervous system disorders, today announced positive results from the pivotal Phase III clinical trial, MS-SPI, which showed evidence of the efficacy and safety of MD1003, a highly-concentrated pharmaceutical-grade biotin administered at a dose of 300 mg per day in the treatment of primary and secondary progressive multiple sclerosis, a major area of unmet medical need.
The primary endpoint was met with a proportion of MS patients showing an improvement in EDSS or TW25 at Month 9 and confirmed at Month 12 (p = 0.0051). The primary endpoint was supported by evidence of a substantial decrease in the risk of disease progression.
The MS-SPI study was a randomized 2:1, double-blinded, placebo-controlled study conducted in 16 MS reference centres in France. Treatment duration was one year.
Medical Need exclusive supply and distribution agreement with French company MedDay Pharmaceuticals, relating to their product MD-1003 (December 12, 2013):