Phase III study of MD1003 in patients with progressive multiple sclerosis meets primary endpoint

MedDay, a biotechnology company focused on the treatment of nervous system disorders, has announced that the primary endpoint was met in its pivotal clinical trial MS-SPI.

MS-SPI investigated the efficacy and safety of MD1003, a highly-concentrated pharmaceutical-grade biotin administered at a dose of 300 mg /day, in the treatment of progressive multiple sclerosis.

The primary endpoint for the study was defined as the proportion of patients who improved at 9 months, with confirmation at 12 months. Detailed data will be presented for the first time at the Clinical Trials Plenary Session at The American Academy of Neurology (AAN) Annual Meeting, Washington DC, on Friday April 24th at 1200 EST.

MD1003 could be an important and efficacious treatment for primary and secondary progressive multiple sclerosis

“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,” said Prof. Ayman Tourbah, Principal Investigator of the study, CHU de Reims, Neurology, France.

“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,” said Frédéric Sedel, MD, Chief Executive Officer of MedDay.

For more information about MedDay, please visit www.medday-pharma.com.