RIBOLIFE-B(06938): The core product VORTOSIRAN has submitted an application for a phase 2b clinical trial for the indication of SPAF.

RIBOLIFE-B(06938) announces that its core product Vortosiran (RBD4059) has successfully submitted a phase 2b clinical trial application (CTA) to the European Medicines Agency (EMA) for stroke prevention in atrial fibrillation (SPAF) patients. This is the first small interfering RNA (siRNA) inhibitor of coagulation factor XI (FXI) in clinical trials for atrial fibrillation (AF), marking an important milestone in the clinical development of siRNA drugs in the field of anticoagulant therapy. This study is part of the company's planned phase 2b studies covering a variety of thromboembolic cardiovascular indications. Vortosiran is an siRNA drug for the treatment of thrombotic diseases designed to accurately and persistently inhibit FXI, blocking the FXI-mediated coagulation pathway and reducing FXI coagulation activity. It provides strong protection against thrombosis while significantly lowering the risk of bleeding compared to existing anticoagulant treatments, enhancing clinical benefits for patients while reducing bleeding risk. Vortosiran is the fastest progressing siRNA drug targeting FXI globally, and as of the announcement date, the product has completed a phase 2a clinical trial in Europe for coronary artery disease (CAD).