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

AInvestFriday, Sep 20, 2024 6:30 am ET
1min read

Sanofi (SNY.US) on Friday presented data from a late-stage trial at a research conference in Copenhagen showing its BTK inhibitor tolebrutinib delayed disability progression in relapsing-remitting MS patients by 31%.

The data corroborated Sanofi's research results published in early September. The company announced on September 2 that tolebrutinib met the primary endpoint of the HERCULES Phase 3 study, effectively delaying disability progression compared to placebo. This is the first and only study to show a reduction in disability accumulation in relapsing-remitting MS.

There is currently no approved treatment for relapsing-remitting MS. Robert Fox, vice-chair of the Cleveland Clinic's Institute of Neurology and a consultant on Sanofi's trial, described the latest trial's findings as a "huge breakthrough." Sanofi plans to submit the drug to global regulators this year.

Analyst John Murphy at Bloomberg Intelligence said in a report that tolebrutinib's success could bring Sanofi up to $1.7 billion in potential revenue, and as much as $3.6 billion in the most optimistic scenario.

However, the trial showed that patients taking tolebrutinib had slightly more adverse events, most notably elevations in liver enzymes. Sanofi said in a statement that one patient had to undergo a liver transplant and died from postoperative complications before the trial implemented stricter monitoring.

Robert Fox said researchers hope to control the adverse events through close monitoring in the first 90 days of treatment. He said if the therapy is approved, patients will need to weigh the risks and benefits with their clinicians.

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