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Home > News > Pharma News > Ribo Biologics announced that the world's first FIH application for a siRNA drug targeting FXI has been successfully approved by HREC in Australia

Ribo Biologics announced that the world's first FIH application for a siRNA drug targeting FXI has been successfully approved by HREC in Australia

yaozh.com 2023-02-09

Recently, Suzhou Ribo Biotechnology Co., Ltd. (hereinafter referred to as "Ribo Biotechnology"), a leading enterprise in China, announced that the antithrombotic oligonucleotide drug (RBD4059 injection) independently developed by Ribo Biotechnology has been approved by HREC in Australia and will start the first human clinical trial in the near future.

 

RBD4059 targets factor XI (factor XI) mRNA, inhibits the protein expression and activity of factor i, blocks the activation of endogenous coagulation pathway, and then achieves anticoagulant/antithrombotic effects, which is expected to become a new safe and effective antithrombotic therapeutic drug.

 

This Phase I clinical trial is a randomized, single-blind, placebo-controlled Phase I study to evaluate the safety, tolerability, and pharmacokinetics of RBD4059 in single dose escalation and multiple dose escalation in healthy subjects, and the results will support the determination of dose selection and dosing regimen in patients in future Phase II clinical trials.

 

RBD4059 is a GalNAc-conjugated siRNA drug independently developed by Ribo Bio based on the RIBO-GalSTARTM liver targeting technology platform with independent intellectual property rights and has global rights, and it is also the world's first drug to enter the clinical clinic for FXI targets. Data from preclinical trials show that RBD4059 has a long-lasting and potent antithrombotic effect with a good safety profile.

 

Anticoagulants are the cornerstone of the prevention and treatment of blood clots, and patients with end-stage renal disease (ESRD), chronic stable coronary heart disease and/or peripheral arterial disease (CAD/PAD), atrial fibrillation (AF), and orthopedic surgery require conventional anticoagulation. At present, the commonly used clinical anticoagulant drugs such as direct oral anticoagulant (DOAC), VKA and heparin have a certain bleeding risk, so it is necessary to develop new anticoagulant drugs with strong effect, low bleeding risk and long-acting to meet the huge clinical demand. RBD4059, a targeted FXI oligonucleotide, is expected to bring significant clinical benefits to these patients.

 

About Ribo Biotech

 

Founded in 2007, Suzhou Ribo Biotechnology Co., Ltd. (hereinafter referred to as "Ribo Biotechnology") is an innovative R&D enterprise dedicated to the development of RNA interference (RNAi) drugs, and is a major pioneer and leader in China's oligonucleotide technology and oligonucleotide pharmaceutical industry.

 

Ribo Biotech benchmarks the innovation frontier of international oligonucleotide technology, is committed to the iterative research and development of oligonucleotide chemical modification and drug delivery technology, and has established an independent and controllable and full-technology chain integrated oligonucleotide drug research and development platform to support the whole life cycle of oligonucleotide drugs from early research and development to industrialization. The self-developed GalNAc oligonucleotide drug delivery technology platform RIBO-GalSTARTM has highly specific liver targeting, high efficiency and long-term characteristics at the international competitive level. The company's pipeline of varieties has advanced to the clinical trial stage. At the same time, Ribo Biotech's research on non-hepatic targeted oligonucleotide delivery technology has made significant progress, which will further support the company's sustainable innovation and development.

 

Ribo Biologics announced that the world's first FIH application for a siRNA drug targeting FXI has been successfully approved by HREC in Australia

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