Sirius Therapeutics Announces Submission to Begin First Clinical Trial of Factor XI siRNA, a Long-Acting Next-Generation Anticoagulant for Thromboembolic Disorders

SAN DIEGO & SHANGHAI--()--Sirius Therapeutics today announced it has submitted an application in Australia to begin a first-in-human clinical trial of SRSD107, its next generation siRNA therapeutic for the prevention and treatment of thromboembolic disorders. SRSD107, which specifically targeting coagulation factor XI (FXI), is the first Sirius-developed compound to reach clinical stage of development globally.

“We have made rapid progress in developing SRSD107 and other candidates in our pipeline since Sirius was established two years ago. This submission marks our transition from discovery to clinical stage development,” said Dr. Qunsheng Ji, Sirius Therapeutics Chief Executive Officer. “The exceptional durability of pharmacology and safety profile suggests SRSD107 has the potential to be a Best- and First-in-class FXI siRNA therapeutic. We aspire to develop SRSD107 as a transformative medicine with a dosing schedule of once semiannually or potentially annually for patients who need chronic anticoagulant.”

About Thromboembolic Disorders

Thrombosis is the common underlying mechanism of most cases of myocardial infarction, ischemic stroke, and venous thromboembolism (VTE). According to a study in The Lancet of reginal 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. Preclinical in vivo studies demonstrated near 100% reduction of FXI levels for up to 6 months, without bleeding events after a single subcutaneous dose.

About Sirius Therapeutics

Sirius is an innovative biotech company developing next generation siRNA therapy for global markets. We are dedicated to discovering and developing new treatment options for cardiovascular disease patients.

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.