The trial included 1,131 participants who had nrSPMS and had no clinical relapses for at least 24 months. The participants were randomized in a 2:1 ratio to receive either tolebrutinib or a placebo, according to a Sept. 20 news release from Sanofi, the drug’s manufacturer.
The study results showed that tolebrutinib delayed the onset of six-month confirmed disability progression by 31% compared to the placebo. Additionally, the drug nearly doubled the number of patients showing improvements in disability, with 10% of tolebrutinib users improving compared to 5% in the placebo group.
The study also noted safety concerns, with a small percentage of patients experiencing elevated liver enzymes and one patient dying after requiring a liver transplant. Sanofi said in the release that it plans to begin regulatory submissions for the drug in the second half of 2024.
