RIBOLIFE-B (06938) Submits Application for Phase 2b Trial of Core Product VORTOSIRAN in SPAF Indication

Stock News04-14

RIBOLIFE-B (06938) announced that its core product, Vortosiran (RBD4059), has successfully submitted a Clinical Trial Application (CTA) to the European Medicines Agency (EMA) for a Phase 2b trial focusing on stroke prevention in atrial fibrillation (SPAF). This trial represents the world's first small interfering RNA (siRNA) Factor XI (FXI) inhibitor to be tested in a clinical trial for atrial fibrillation (AF), marking a significant milestone in the clinical development of siRNA therapies within the anticoagulation field. This study is part of the company's broader strategy, which includes multiple planned Phase 2b trials targeting various thromboembolic cardiovascular indications. Vortosiran is an siRNA therapeutic designed for thrombotic disorders. It works by providing precise and sustained inhibition of FXI, thereby blocking the FXI-mediated coagulation pathway and suppressing FXI clotting activity. This mechanism offers robust protection against thromboembolism while significantly reducing the risk of bleeding. Compared to existing anticoagulation treatments, Vortosiran has the potential to lower bleeding risks and enhance clinical benefits for patients. Vortosiran is the most advanced small nucleic acid drug globally that targets FXI. As of the date of this announcement, the product has already completed a European Phase 2a clinical trial for Coronary Artery Disease (CAD).

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