A phase 3 study has shown that tolebrutinib, a drug being tested in treating non-relapsing secondary progressive multiple sclerosis, slowed the progression of disability in patients.
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.