Sirius Therapeutics Announces EMA Submission to Initiate a Phase 2 Clinical Trial of SRSD107, a Long–Acting, Next-Generation Anticoagulant for Thromboembolic Disorders
March 12th, 2025
March 12th 2025, SAN DIEGO & SHANGHAI - Sirius Therapeutics today announces it has submitted a clinical trial application to the European Medicines Agency (EMA) to begin a Phase 2 clinical trial of SRSD107, a next generation, long-acting Factor XI (FXI) siRNA for the treatment of thromboembolic disorders. The submission to the EMA represents an important first step in gaining regulatory approval to conduct the clinical trial and paves the way for the initiation of the trial in multiple European countries.
SRSD107 is designed to prevent the synthesis of FXI, a protein in the coagulation pathway that plays a key role in pathologic thrombosis but not physiological hemostasis. As such, the inhibition of FXI has shown potential to reduce thrombosis without increasing the risk of bleeding, a significant limitation of current anti-thrombotic therapies.
“The company’s initial Phase 2 clinical trial, SRSD107-201, is designed to evaluate the safety of SRSD107, as well as its efficacy for the prevention of venous thromboembolism in patients undergoing total knee arthroplasty,” said Dr. Patrick Yue, Sirius’ Chief Medical Officer. “The trial aims to validate the anticoagulant benefit of SRSD107 and provide a solid basis for a dose regimen in subsequent pivotal trials. We look forward to working closely with clinical trial sites across Europe to advance this trial.”
The Phase 2 trial follows a promising Phase 1 clinical trial, in which single doses of SRSD107 were found to be safe and well tolerated, and demonstrated robust and prolonged reductions in FXI antigen and increases in activated partial thromboplastin time. Results from the trial were presented in December 2024 at the annual meeting of the American Society of Hematology (ASH) 1.
Dr. Qunsheng Ji, Sirius Chief Executive Officer, added that “Sirius is committed to addressing the unmet medical needs of patients with cardiovascular and cerebrovascular thromboembolic disorders. This milestone underscores our approach to developing our advanced therapies for worldwide use.”
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 trial in The Lancet 2of regional and global mortality rates, thromboembolic disorders are estimated to cause as many as 1 in 4 deaths worldwide.
About SRSD107
SRSD107 is a novel double-stranded small interfering ribonucleic acid (siRNA). Developed by Sirius Therapeutics, SRSD107 specifically targets the human 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 a clinical stage biotech company developing innovative siRNA therapies for global markets. We are dedicated to discovering and developing new treatment options for cardiovascular and cerebrovascular diseases and translating siRNA technology into transformative siRNA therapeutics for patients with chronic diseases. 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 innovation 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, and Delos Capital.
Reference:
1. Blood (2024) 144 (Supplement 1): 4009.
2. Lozano R, Naghavi M, Foreman K, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380, 2095-1128.
