Ruibo Biotechnology's siRNA new drug has been approved for phase 2 clinical trials in Europe.

On May 29th, Ruibo Biotech announced that its self-developed anti-thrombotic siRNA drug targeting FXI, RBD4059, has recently obtained approval for Phase 2 clinical trials from the European Medicines Agency (EMA). This is a randomized, double-blind, placebo-controlled Phase 2 clinical study aimed at evaluating the safety, efficacy, and pharmacokinetics of RBD4059 in stable coronary artery disease patients. RBD4059 is a GalNac-conjugated siRNA drug developed by Ruibo Biotech based on its liver-targeting technology platform. By inhibiting coagulation factor XI (FXI) and blocking the activation of the intrinsic coagulation pathway, it achieves its anticoagulant/anti-thrombotic effects. According to Ruibo Biotech's press release, inhibiting FXI is expected to be a more effective anti-thrombotic treatment compared to current therapies, with a lower risk of bleeding. In Phase 1 clinical trials, RBD4059 demonstrated good safety and efficacy. According to data previously presented by Ruibo Biotech at the 2023 European Society of Cardiology (ESC) Congress, preclinical studies showed that the product has a highly effective and sustained inhibitory effect on FXI expression and activity, with expected long-term efficacy in clinical settings, improving patient compliance. Dr. Liang Zicai, Chairman and CEO of Ruibo Biotech, stated that RBD4059 has the potential for ultra-long-acting anti-thrombotic effects with injections every six months, and is expected to bring benefits to patients. He is very pleased that the drug has received Phase 2 clinical approval from the EMA. Based on Ruibo Biotech's differentiated development strategy, they will continue to launch more innovative nucleic acid drugs to bring substantial clinical benefits to patients as soon as possible.