Ribocure Pharmaceuticals AB announces authorization to start a Phase II clinical trial in Sweden for the world’s first siRNA drug targeting Factor XI: RBD4059

On May 27, 2024, Ribocure Pharmaceuticals AB and Suzhou Ribo Life Science Ltd (Ribo) received authorization from the Swedish Medicinal Product Agency (MPA), to initiate a Phase II clinical trial in Sweden with the world’s first and most advanced anti-thrombotic siRNA drug, RBD4059 targeting FXI. The trial will evaluate safety, pharmacokinetics and pharmacodynamics of its novel siRNA asset RBD4059, in patients with stable coronary artery disease.

This is a randomized, double-blind, placebo-controlled phase II trial to evaluate safety, pharmacokinetics and pharmacodynamics of RBD4059 in participants with stable coronary artery disease. The study aims to demonstrate proof of principle and confirm dose response in the target population. The study will be run at Ribocure Clinic, a specialized phase II unit for high quality functional imaging proof of principle trials, based in GoCo Health Innovation City, Sweden.

Anticoagulant drugs are cornerstones of the prevention and treatment of thrombosis in many patient populations, including coronary artery disease, peripheral artery disease, end-stage renal disease (ESRD), atrial fibrillation (AF) and venous thrombo-embolism (VTE) orthopedic surgery, etc. Common and currently used anticoagulants, such as direct oral anticoagulants (DOAC), Vitamin K antagonists (VKAs) and heparin, are all associated with various degree of clinical bleeding risk and skewed benefit-risk that prohibits its wider use, in e.g. frail patients or patients with higher bleeding risk and great unmet need of anti-thrombotic therapy.

RBD4059 is a GalNac-conjugated siRNA drug based on the RIBO-GalSTARTM liver targeting technology platform and achieves its anti-thrombotic effects by suppressing FXI concentrations and inhibiting the intrinsic pathway of the coagulation cascade. People with naturally occurring low levels of FXI are at lower risk of having thrombosis and without signs of increased spontaneous bleeding risk. Therefore, inhibiting FXI holds the promise to be an efficacious antithrombotic therapy with minimal bleeding risk compared to current available therapies. RBD4059 showed promising safety and pharmacodynamic data in healthy volunteers, and data will be shared at the upcoming European Society of Cardiology meeting in London this year.

“We are very excited to have achieved the approval from MPA and thereby accelerate the development for patients in need, as the world´s first and most advanced siRNA program for FXI” says Li-Ming Gan, CEO Ribocure Pharmaceuticals AB.

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