Sanofi Reveals Late-Stage Data For Fitusiran In Hemophilia Patients

Sanofi SA SNY presented data from two Phase 3 studies of fitusiran for the prophylactic treatment with hemophilia A or B, with or without inhibitors.

• Data were shared at the American Society of Hematology (ASH) Annual Meeting. 
• Fitusiran, an RNAi drug designed to silence the gene that overproduces a protein responsible for clotting suppression.
• Fitusiran cut patients’ annualized bleeding rate (ARB) rate by 89% over control, demonstrating prophylactic for bleeding episodes as a once-monthly injection. 
• In this Phase 3 study, dubbed ATLAS-A/B, 50.6% of patients treated with fitusiran had zero treated bleeds during the study compared with just 5% of patients in the on-demand arm.
• Sanofi revealed safety data from ATLAS-A/B with 19% of patients in the fitusiran arm reporting abnormally high levels of ALT and AST proteins. Meanwhile, there were no reported cases of thrombosis.
• Sanofi reported updated results from ATLAS-INH showing 24.4% of patients in the study had abnormally high levels of ALT/AST, and two patients presented suspected or confirmed thrombosis. 
• Price Action: SNY shares are down 1.05% at $48.26 during the market session on the last check Tuesday.
• Check out our coverage of the American Society of Hematology (ASH) Annual Meeting 2021 here.