The company’s anti-coagulant is designed to stop the formulation of Factor XI, with the aim of cutting rates of thrombosis without significantly increasing the rate of bleeding. Credit: Shutterstock / Iryna Zastrozhnova

Joint US and China-based healthcare firm Sirius Therapeutics’s SRSD107 was safe and well tolerated in a Phase I first-in-human trial.

The treatment under clinical development for the prevention and treatment of thromboembolic disorders such as myocardial infarction, ischemic stroke and venous thromboembolism.

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Data presented during the 66th American Society of Hematology (ASH) Annual Meeting in San Diego showed that SRSD107 was safe and well-tolerated. The trial marked changes in pharmacodynamics (PD) biomarkers and maximal reductions in factor XI (FXI) antigen and activity > 90% and an aPTT (thromboplastin time) increase of > 100% at the highest doses tested. The PD effects were durable with activity levels remaining suppressed for more than 16 weeks after dosing.

The company’s anti-coagulant is designed to stop the formulation of Factor XI, with the aim of cutting rates of thrombosis without significantly increasing the rate of bleeding like current standards of care.

The ongoing single-site, randomised, double-blind, placebo-controlled study (NCT06116617) sought to examine the safety, tolerability, pharmacokinetics (PK) and PD of subcutaneously administered SRSD107 in 40 healthy subjects. Five cohorts, each consisting of eight subjects evaluated eight doses of SRSD107, each receiving either a single dose of SRSD107 or a placebo. The trial began at the start of 2024 and is set to run through to the start of 2025.

The company said the data supports progression to Phase II studies.

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SRSD107 is described by the company as a novel double-stranded small interfering ribonucleic acid (siRNA), that specifically targets human coagulation FXI. It works by blocking the intrinsic coagulation pathway and promoting anticoagulant and anti-thrombotic effects. The treatment has been engineered with the intent of being administered twice yearly.

Patrick Yue, Sirius’ chief medical officer, said: “We are encouraged by the marked, prolonged reduction in FXI antigen and activity, and increase in clotting, or thromboplastin time, that are consistent potent anticoagulation over sustained periods and reduced bleeding risk respectively. The trial provides a strong foundation for Phase II clinical studies.”

The announcement follows after the company applied for an application in Australia to commence a first-in-human clinical trial of SRSD107 as the company looks to expand its ongoing trials. Elsewhere in the same field, AstraZeneca and UK biotech Aptamer Group are hoping to bolster the efficacy of their own siRNA therapies, using Aptamer’s Optimer delivery system.