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Sirius Therapeutics Commences Phase 1 Clinical Trial for Next-Generation, Extended-Release Factor XI siRNA Anticoagulant in Treating Thromboembolic Disorders

Friday, February 02, 2024

Sirius Therapeutics has recently initiated the Phase 1 clinical trial of SRSD107 in Australia on January 30th, 2024. SRSD107 is a next-generation siRNA therapeutic designed to target coagulation Factor XI (FXI) for the prevention and treatment of thromboembolic disorders. This represents the second clinical candidate in the company's portfolio of siRNA therapeutics for cardiovascular diseases, following the start of clinical trials for SRSD101 in China, addressing dyslipidemia.

Sirius Therapeutics, emphasized that the trial is based on promising in vivo studies demonstrating nearly 100% reduction in FXI levels for up to 6 months without bleeding events after a single subcutaneous dose. The Phase 1 study, conducted in healthy volunteers in Australia, aims to assess SRSD107's safety, tolerability, pharmacokinetics, and pharmacodynamics through single ascending doses and multiple ascending doses.

Thromboembolic disorders, characterized by blood clot formation, underlie many cardiovascular conditions such as myocardial infarction, ischemic stroke, and venous thromboembolism. According to global mortality studies in The Lancet, these disorders contribute to approximately 1 in 4 deaths worldwide.

SRSD107, a novel double-stranded small interfering ribonucleic acid (siRNA) developed by Sirius Therapeutics, specifically targets FXI mRNA to inhibit FXI protein expression. This action blocks the intrinsic coagulation pathway, promoting anticoagulant and anti-thrombotic effects. Engineered for potential once or twice-a-year dosing, SRSD107 offers a differentiated therapeutic approach for the treatment of thromboembolic disorders on a global scale.



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