MedDay Pharmaceuticals has completed patient enrolment in the SPI2 Phase III clinical trial evaluating MD1003 for the treatment of progressive multiple sclerosis (MS).
SPI2 is MedDay’s second Phase III clinical trial that aims to confirm and further support the positive results from the company’s previous trial of MD1003.
It features a randomised, double-blind, placebo-controlled design.
The trial’s endpoint is to measure reversal of disease progression on 642 patients for a prolonged treatment period of at least 15 months.
Secondary endpoints include time to progression of the expanded disability status scale (EDSS) score and average change in the timed 25-foot walk (TW25) test score.
The trial is being carried out across 90 clinical study centres across the US, Canada, Europe and Australia.
MedDay is expected to provide data from the SPI2 trial in the first quarter of 2020.
The company also plans to submit marketing authorisation applications to regulatory agencies in the US and Europe by the second half of 2020.
MedDay Pharmaceuticals CEO Christian Chavy said: “The mechanism of action of our MD1003 experimental product has the potential to have a significant impact in the treatment of progressive multiple sclerosis.
“MedDay is fully committed to developing its clinical program with the aim of offering a therapeutic alternative to patients.”
MS is a demyelinating disease that damages the insulating covers of nerve cells in the brain and spinal cord.