RiboBio Announces First-in-Class FXI-Targeting siRNA Drug RBD4059 Receives HREC Approval in Australia for First-in-Human Clinical Trial

Recently, Suzhou Ribo Life Science Co., Ltd. (referred to as "Ribo Life Science"), a leading Chinese small nucleic acid company, announced that its self-developed anti-thrombotic small nucleic acid drug (RBD4059 injection) has received HREC approval in Australia and will initiate its first human clinical trial soon.

RBD4059 targets FXI (Factor XI) mRNA, inhibits FXI protein expression and activity, blocks the activation of the intrinsic coagulation pathway, and thereby achieves anticoagulant/antithrombotic effects. It is expected to become a new type of safe and effective antithrombotic therapeutic drug.

This Phase I clinical trial is a randomized, single-blind, placebo-controlled Phase I study designed to evaluate the safety, tolerability, and pharmacokinetics of RBD4059 in healthy subjects with single ascending doses and multiple ascending doses. The results will support dose selection and dosing regimens for future Phase II clinical trials.

RBD4059 is a GalNAc-conjugated siRNA drug independently developed by Ribo Life Science based on its proprietary RIBO-GalSTARTM liver-targeting technology platform, for which it holds global rights. It is also the world's first drug of this kind targeting FXI to enter clinical trials. Preclinical trial data show that RBD4059 has a long-lasting and potent antithrombotic effect while maintaining good safety.

Anticoagulant drugs are the cornerstone for the prevention and treatment of thrombosis. Patients with end-stage renal disease (ESRD), chronic stable coronary artery disease and/or peripheral artery disease (CAD/PAD), atrial fibrillation (AF), post-orthopedic surgery, etc., all require routine anticoagulation therapy. Currently, commonly used anticoagulants in clinical practice, such as direct oral anticoagulants (DOACs), VKAs, and heparin, carry a certain risk of bleeding. Therefore, there is a need to develop new anticoagulants that are potent, have a low risk of bleeding, and are long-acting to meet significant clinical demands. The FXI-targeting small nucleic acid drug RBD4059 is expected to bring substantial clinical benefits to these patients.

About Ribo Life Science

Suzhou Ribo Life Science Co., Ltd. (referred to as "Ribo Life Science") was established in 2007. It is an innovative R&D enterprise dedicated to developing RNA interference (RNAi) drugs and is a major pioneer and leading company in China's small nucleic acid technology and small nucleic acid pharmaceuticals industry.

Ribo Life Science benchmarks the innovative frontier of international small nucleic acid technology, committing to the iterative R&D of small nucleic acid chemical modification and drug delivery technologies. It has established an independent, controllable, and fully integrated small nucleic acid drug R&D platform that supports the entire lifecycle of small nucleic acid drugs from early-stage R&D to industrialization. The self-developed GalNAc small nucleic acid drug delivery technology platform, RIBO-GalSTARTM, features highly specific liver targeting, high efficiency, and long-lasting effects, reaching an internationally competitive level. Multiple product pipelines of the company have advanced to the clinical trial stage. Meanwhile, significant progress has been made in Ribo Life Science’s non-liver-targeting small nucleic acid delivery technology research, further supporting the sustainable and innovative development of the company.

Editor: Pea Shooter

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