MedDay's Phase III trial of multiple sclerosis therapy meets primary endpoint

Privately-owned MedDay Pharma’s Phase III experimental drug MD1003 in patients with progressive multiple sclerosis met its primary endpoint.

The MS-SPI trial randomized 154 patients with progressive MS who have demonstrated progression in the two years prior to enrolment to receive either MD1003 or placebo. MedDay noted that patients with a baseline Expanded Disability status scale score of between 4.5 and 7 were enrolled, and treatment duration was of one year. The main goal was the proportion of patients who improved at nine months with confirmation at 12 months, while secondary endpoints evaluated the effect of the therapy in stabilizing or slowing down the rate of progression.

Frédéric Sedel, chief executive of MedDay, 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."