Sirius Therapeutics Begins Phase 1 Clinical Trial of Next-Generation, Long-Acting Factor XI siRNA Anticoagulant for Treatment of Thromboembolic Disorders

(BUSINESS WIRE) -- Sirius Therapeutics, announced it has dosed the first subject in a Phase 1, first-in-human clinical trial in Australia of SRSD107 on January 30^th 2024, its next generation siRNA therapeutic targeting coagulation Factor XI (FXI), for the prevention and treatment of thromboembolic disorders. SRSD107 is the second clinical candidate in the company’s portfolio of next generation siRNA therapeutics to treat cardiovascular diseases. The company recently began clinical trials of SRSD101 in China for the treatment of dyslipidemia following IND clearance from the China National Medical Products Administration.

“This trial is based on in vivo studies that demonstrated a nearly 100% reduction of FXI levels for up to 6 months, without bleeding events, after a single subcutaneous dose,” said Dr. Qunsheng Ji, Sirius Therapeutics’ Chief Executive Officer. “The trial will provide an opportunity to evaluate SRSD107’s potential as a differentiated therapeutic for these common disorders globally.”

The SRSD107 Phase 1 study, which is being conducted in healthy volunteers in Australia, will evaluate SRSD107’s safety, tolerability, pharmacokinetics, and pharmacodynamics at single ascending doses and multiple ascending doses.

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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