Phase 2B clinical trial of VORTOSIRAN, the core product of Ruibo Bio-B (06938), against SPAF was approved by EMA

Zhitongcaijing · 1d ago

Zhitong Finance App News, Ruibo Bio-B (06938) announced that the European Medicines Agency (EMA) has approved the launch of the phase 2b clinical trial Orbit-XI-AF to evaluate vortosiran (RBD4059). This is the world's first and most advanced small-interfering nucleic acid (siRNA) therapy targeting XI coagulation factor (FXI) for stroke prevention (SPAF) in patients with atrial fibrillation. The approval of this phase 2b multi-regional clinical trial (MRCT) marks an important milestone for vortosiran and highlights the global development strategy for the next generation of anticoagulants. This also enabled the company to advance the project to the next stage of global clinical development.

Vortosiran is a GalNAC-conjugated siRNA candidate developed independently based on the RibogalStartM liver targeting technology platform. By specifically inhibiting FXI synthesis, vortosiran blocks endogenous coagulation pathways and achieved potent antithrombotic activity. Strong human genetic evidence shows that people with naturally low FXI levels are less likely to develop thrombotic diseases and do not increase the risk of spontaneous bleeding. Therefore, FXI inhibition has become a promising potential treatment. It can not only effectively prevent thrombosis, but also has higher safety compared to existing anticoagulant therapies.