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news.French biotechnology firm MedDay has reported positive results from its pivotal Phase III clinical trial (MS-SPI) of its investigational medicine, MD1003, to treat progressive multiple sclerosis (MS).
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The randomized, double-blind, multicenter, placebo-controlled (2:1) MS-SPI trial evaluated the efficacy and safety of MD1003, 300mg/day, in patients with progressive MS who have showed progression in the two years prior to enrolment.
The trail met its primary endpoint, which was defined as the proportion of patients who improved at nine months, with confirmation at 12 months.
CHU de Reims Neurology and principal investigator of the study, professor Ayman Tourbah said: "We are encouraged that the primary endpoint was met despite the very high bar for treatment response.
"This result, which will be disclosed at AAN on April 24th along with supportive analyses and safety data, suggests that MD1003 could be an important and efficacious treatment for primary and secondary progressive multiple sclerosis."
In the trial, a total of 154 patients with a baseline expanded disability status scale (EDSS) score of between 4.5 and seven were enrolled from 16 MS reference centers across France.
MedDay chief executive officer Frédéric Sedel said: "The trial design and dosing were discussed with US and European regulators and we are pleased the results demonstrate evidence of improvement at one year in patients with progressive worsening MS."
MD1003 is thought to have both pro-myelinotic effects and to improve the supply of energy for nerve impulse transmission.