Sirius Therapeutics Highlights Positive Phase I Data for SRSD107, a Potential First-in-Class and Best-in-Class siRNA Anticoagulant Therapy

On December 10, 2024, Sirius Therapeutics (SHANGHAI) Co., Ltd. (Sirius Therapeutics) announced that the company presented the latest data from the Phase I clinical trial of SRSD107 at the 66th American Society of Hematology (ASH) Annual Meeting.

SRSD107 is a next-generation siRNA therapy that specifically targets anticoagulant Factor XI, used for the prevention and treatment of thromboembolic diseases such as myocardial infarction, ischemic stroke, and venous thromboembolism.SRSD107: Potent and Long-LastingEfficacy and good safety,Expected to become a potential First-in-Class and Best-in-Class new generation of safer anticoagulant drugs.

The title of this study is "A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Administration of SRSD107 in Healthy Subjects."Radiation, Single-Dose Escalation, Phase I Clinical Study".This trial is a single-center, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneous SRSD107 in 40 healthy subjects. The study includes five cohorts, each consisting of eight subjects.

In the study, SRSD107 demonstrated good safety and tolerability, with significant changes in pharmacodynamic biomarkers observed from baseline.At the highest dose, the maximum reduction in FXI antigen and FXI activity exceeded 90%, and the increase in aPTT exceeded 100% (i.e., aPTT ratio > 2.0).The pharmacodynamic effect persists after a single dose.Maintaining FXI antigen and FXI activity at nearly 90% inhibition for over 16 weeks.

SRSD107 Injection is a double-stranded small interfering RNA (siRNA) drug independently developed by Sirius Therapeutics. By specifically targeting the liver-directed human coagulation factor XI (FXI) mRNA, it inhibits the protein expression of FXI, blocking the activation of the intrinsic coagulation pathway, thereby exerting an anticoagulant effect. Preclinical trial data show that a single subcutaneous injection of SRSD107 can reduce the concentration of FXI in peripheral blood by nearly 100%, with effects lasting up to half a year without any observed bleeding. SRSD107 demonstrates both potent and long-lasting efficacy as well as good safety.Expected to become a potential First-in-Class and Best-in-Class new generation of safer anticoagulant drugs.