MD1003: Phase III data

The double-blind, French Phase III MS-SPI trial in 154 patients with primary or secondary progressive MS showed that once-daily 300 mg MD1003 met the primary endpoint of a greater proportion of patients who improved at 9 months, with a confirmation at 12 months, vs. placebo (12.6% vs. 0%, p=0.0051). Improvement was defined as either a reduction in EDSS of >=1 point for baseline EDSS of <=5.5 points or a reduction of >=0.5 points for baseline EDSS of >= 6 points, or an improvement in TW25 of >=20%. On secondary endpoints, MD1003 significantly reduced mean EDSS score from baseline to 12 months vs. placebo (reduction of 0.3 points vs. an increase of 0.13 points, p=0.015). Additionally, 4% of patients receiving MD1003 experienced EDSS progression at 9 months confirmed at 12 months vs. 13% of patients receiving placebo (p=0.07). Medday said the trial was not powered for significance on the secondary progression endpoint. ...