RiboBio's First-in-Class FXI-Targeting siRNA Antithrombotic Drug RBD4059 Granted Phase II Clinical Trial Authorization by EMA

On May 29, 2024, Suzhou Ribo Life Science Co., Ltd. ("Ribo Life Science") announced that its self-developed RBD4059, the world’s first anti-thrombotic siRNA drug targeting FXI, had recently received Phase II clinical trial approval from the European Medicines Agency (EMA). This trial is a randomized, double-blind, placebo-controlled Phase II clinical study aimed at evaluating the safety, efficacy, and pharmacokinetics of RBD4059 in patients with stable coronary artery disease. The trial has also been approved to be conducted at Ribo Life Science’s European R&D center’s own Phase II clinical site, which meets EU and US regulatory standards.

Anticoagulant drugs are fundamental medications for the prevention and treatment of thrombosis, with a wide range of indications including coronary artery disease, peripheral artery disease, end-stage renal disease (ESRD), atrial fibrillation (AF), venous thromboembolism (VTE), and post-operative care in orthopedic surgeries. Currently used anticoagulants in clinical practice, such as direct oral anticoagulants (DOACs), VKAs, and heparin, all carry a certain risk of bleeding. Therefore, there is a significant clinical demand for novel anticoagulants that are potent, long-lasting, and have a low risk of bleeding.

RBD4059 is a product of Ribo Life Science based on RIBO-GalSTAR.^TMRBD4059, a GalNac-conjugated siRNA drug independently developed by the liver-targeting technology platform with global rights, achieves its anticoagulant/antithrombotic effect by inhibiting FXI and blocking the activation of the intrinsic coagulation pathway. Compared with current treatment methods, inhibiting FXI is expected to become a more effective antithrombotic treatment with minimal risk of bleeding. In Phase I clinical trials, RBD4059 demonstrated good safety and efficacy, and relevant data will be announced at this year's European Society of Cardiology (ESC Congress) meeting to be held in London.

     Dr. Zicai Liang, Chairman and CEO of Ribo Life Science, stated:"RBD4059 is the world's first siRNA-based small nucleic acid drug targeting FXI, and it is also our RIBO-GalSTAR"^TMAnother significant achievement from the liver-targeting platform. RBD4059 has the ultra-long-acting antithrombotic potential of one injection every six months, which is expected to bring benefits to patients. We are very pleased that this drug has received Phase II clinical approval from the EMA. Based on Ribo Life Science’s Best-in-Class/First-in-Class differentiated development strategy, we will continue to launch more innovative small nucleic acid drugs to bring substantial clinical benefits to patients as soon as possible.”