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Results of compounds in late stages of development

Presented By
Dr B.A.C. Cree, Dr D.S. Reich, Dr E. Jasińska
EAN 2020
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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