Sanofi's (SNY.US) BTK inhibitor Tolebrutinib effectively delays disability progression in MS patients.

At a research conference in Copenhagen on Friday, Sanofi (SNY.US) presented late-stage trial data showing that its BTK inhibitor Tolebrutinib can delay disability progression in patients with non-relapsing secondary progressive multiple sclerosis (MS) by 31%. This data confirms the research results published by Sanofi in early September. The company announced on September 2 that Tolebrutinib met the primary endpoint in the HERCULES Phase III study - the drug can effectively delay disability progression compared to placebo. This is the first and only study to show a reduction in disability accumulation in non-relapsing secondary progressive multiple sclerosis (MS). It is reported that there is currently no approved treatment for non-relapsing secondary progressive multiple sclerosis. Robert Fox, vice chairman of the Neurological Research Institute at the Cleveland Clinic and a trial consultant for Sanofi, described the latest trial findings as a "huge breakthrough." Sanofi plans to submit the drug to global regulatory agencies this year. Bloomberg Intelligence analyst John Murphy stated in a report that the success of Tolebrutinib could bring potential revenue of $1.7 billion to Sanofi, and in the most optimistic scenario, it could bring in $3.6 billion in revenue. However, the trial showed that patients receiving Tolebrutinib treatment experienced slightly more adverse events, with the most concerning being elevated liver enzymes. Sanofi stated in a statement that one patient had to undergo a liver transplant and died due to postoperative complications before stricter monitoring was implemented in the trial. Robert Fox stated that researchers hope to control the occurrence of adverse events within the first 90 days of treatment through close monitoring. He mentioned that if the therapy is approved, patients will need to weigh the risks and benefits of the treatment with their clinical physician.