Home > Neurology > EAN 2020 > Multiple Sclerosis > Results of compounds in late stages of development

Results of compounds in late stages of development

Presented By
Dr B.A.C. Cree, Dr D.S. Reich, Dr E. Jasińska
Conference
EAN 2020
Trial
Phase 3, EVOLVE-MS-1, SPI2
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 [1]. There were positive phase 2b trial results of the Bruton’s tyrosine kinase (BTK) inhibitor SAR442168 [2], and positive phase 3 results of oral diroximel fumarate (DRF) [3]. In the SPI2 trial, 642 patients were randomised to MD1003 (n=326) or placebo (n=316) [1]. 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 v...


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