Sirius Therapeutics, a pioneering biotechnology firm, has marked a significant milestone in the development of novel treatments for cardiovascular diseases by dosing the first subject in a Phase 1, first-in-human clinical trial of SRSD107 in Australia. SRSD107, a next-generation siRNA therapeutic, targets coagulation Factor XI (FXI) and is designed for the prevention and treatment of thromboembolic disorders. This development positions SRSD107 as the second clinical candidate in Sirius Therapeutics’ portfolio, closely following the initiation of clinical trials for SRSD101 in China for dyslipidemia treatment after receiving IND clearance from the China National Medical Products Administration.

The decision to advance SRSD107 into clinical trials is supported by in vivo studies showcasing a nearly 100% reduction in FXI levels for up to six months, remarkably without any bleeding events, after a single subcutaneous dose. “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,” stated Dr. Qunsheng Ji, Chief Executive Officer of Sirius Therapeutics. He further emphasized, “The trial will provide an opportunity to evaluate SRSD107’s potential as a differentiated therapeutic for these common disorders globally.”

The Phase 1 study of SRSD107, being conducted in healthy volunteers in Australia, aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug at single ascending doses and multiple ascending doses. SRSD107 represents a cutting-edge approach in anticoagulation therapy, utilizing a novel double-stranded small interfering ribonucleic acid (siRNA) mechanism. By specifically targeting coagulation factor XI (FXI) mRNA and inhibiting FXI protein expression, SRSD107 effectively blocks the intrinsic coagulation pathway, offering promising anticoagulant and anti-thrombotic effects. The therapeutic has been engineered with the potential for once or twice-a-year dosing, heralding a new era in the management of thromboembolic disorders.

The initiation of the SRSD107 Phase 1 trial underscores Sirius Therapeutics’ commitment to advancing cardiovascular disease treatment through innovative siRNA therapeutics. With the potential for extended dosing intervals and a strong safety profile demonstrated in preclinical studies, SRSD107 could significantly impact the treatment landscape for patients with thromboembolic disorders. As the trial progresses, the medical community eagerly anticipates further data that could redefine standard care practices for these globally prevalent conditions.

  China, Dr. Qunsheng Ji, Sirius Therapeutics, SRSD107