MD1003 (high-dose pharmaceutical-grade biotin) did not meet any of the primary or secondary endpoints in patients with progressive multiple sclerosis (MS) in the SPI2 trial . There were positive phase 2b trial results of the Bruton’s tyrosine kinase (BTK) inhibitor SAR442168 , and positive phase 3 results of oral diroximel fumarate (DRF) .
In the SPI2 trial, 642 patients were randomised to MD1003 (n=326) or placebo (n=316) . Of the participants, 64.6% had secondary progressive MS; mean Expanded Disability Status Scale (EDSS) was 5.4, mean Timed 25-Foot Walk (TW25) 11.6 seconds. The double-blind period was 15-27 months. The primary endpoint, the proportion of patients with improvement in EDSS or TW25 (>20%), was not significantly different. The rate of EDSS or TW25 responders was 12.0% in the MD1003 group versus 9.2% in the placebo group (OR 1.35; 95% CI 0.81-2.26). In a subgroup anal...
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