Sirius Therapeutics Announces Dosing of First Subject in Chinese Phase 1 Clinical Trial of FXI siRNA Anticoagulant

April 01st, 2024

SAN DIEGO, CA & SHANGHAI, April 1st, 2024 - Sirius Therapeutics today announced it has dosed the first subject in a Chinese Phase 1 trial of SRSD107, its next generation siRNA therapeutic targeting coagulation Factor XI (FXI), for the prevention and treatment of thromboembolic disorders. This study is to evaluate SRSD107 safety, tolerability, pharmacokinetics and pharmacodynamics at single ascending doses. Currently SRSD107 phase-1 study is also being conducted in Australia, with the first two cohorts completed and progressing well.

“We are pleased with the Chinese FSI completed as part of the global development of SRSD107. This milestone could not have been achieved without strong support by the physicians of the study, Sirius’ team as well as our partners. We look forward to further advancing SRSD107 development to benefit patients soon,” said Dr. Qunsheng Ji, CEO and Executive Director at Sirius Therapeutics. “SRSD107 is a novel siRNA therapeutics that has potential for twice-a-year dosing to uncouple hemostasis from thrombosis by targeting Factor XI, providing a differentiated anticoagulant therapy for those common disorders globally.” 




About Thromboembolic Disorders

Thrombosis, or blood clot formation, is the common underlying mechanism of most cases of myocardial infarction, ischemic stroke, and venous thromboembolism. According to a study in The Lancet of regional and global mortality, thromboembolic disorders are estimated to cause 1 in 4 deaths worldwide1.


About SRSD107

SRSD107 is a novel double-stranded small interfering ribonucleic acid (siRNA). Developed by Sirius Therapeutics, SRSD107 specifically targets coagulation factor XI (FXI) mRNA and inhibits FXI protein expression, thereby blocking the intrinsic coagulation pathway and promoting anticoagulant/anti-thrombotic effects. SRSD107 has been engineered for the potential to enable once or twice-a-year dosing.


About Sirius Therapeutics

Sirius is an innovative, clinical stage biotech company developing next generation siRNA therapy for global markets. We are dedicated to discovering and developing new treatment options for cardiovascular disease patients. Our most advanced products are SRSD107 for the treatment of thromboembolic disorders, and SRSD101 for the treatment of dyslipidemia. Founded in 2021 by a world-class leadership team and investors, Sirius has established an innovative discovery center in the United States and translational medicine center in China. Sirius has raised nearly US$100 million funding to date from OrbiMed, Creacion Ventures, Hankang Capital, Delos Capital, and the leadership team.


[1] Lozano R, Naghavi M, Foreman K, et al. Lancet. 2012;380, 2095-1128.

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