Sirius Therapeutics Announces First-in-Class siRNA Anticoagulant SRSD107 Completes First Patient Dosing in China Phase I Trial and Submits Hong Kong IPO Application

April 1, 2024, Shanghai, China, and San Diego, USA: Sirius Therapeutics (SHANGHAI) Co., Ltd. ("Sirius Therapeutics"), announced today that the first subject dosing has been successfully completed in the Phase I clinical trial in China for SRSD107 Injection, its self-developed novel anticoagulant small nucleic acid drug. This is a randomized, double-blind, placebo-controlled, single ascending dose clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SRSD107. SRSD107 is also concurrently undergoing Phase I clinical trials in Australia, where dosing for the first two dose cohorts has been completed, with current progress proceeding smoothly.

SRSD107-102 China Phase I Kick-off Meeting

Image Source: Sirius Therapeutics Official WeChat

Dr. Ji Qunsheng, CEO and Executive Director of Sirius Therapeutics, stated: "We are very pleased that SRSD107 has reached another significant milestone in clinical development. The rapid initiation and advancement of this study would not have been possible without the strong support of the Clinical Research Center team at Beijing Tiantan Hospital, as well as the joint efforts of the project team. We look forward to the rapid progress of this project and achieving positive outcomes, ultimately benefiting patients sooner. SRSD107 is a novel anticoagulant therapy that combines the dual mechanism features of FXI, which decouples hemostasis from thrombosis, with the long-lasting effects of siRNA. It offers both safety and durability, holding the potential to revolutionize traditional anticoagulant drugs."

About Thromboembolism

Thrombosis is a blood clot that restricts blood flow within blood vessels and can occur in either arterial or venous circulation. It is the common pathological basis for most myocardial infarctions, ischemic strokes, and venous thromboembolism (VTE). Globally, one in four people die from diseases caused by thromboembolism.

About SRSD107 Injection

SRSD107 Injection is a double-stranded small interfering RNA (siRNA) drug independently developed by Sirius Therapeutics, with proprietary intellectual property rights. By specifically targeting the liver-directed coagulation factor XI (FXI) mRNA, it inhibits the protein expression of FXI and blocks the activation of the intrinsic coagulation pathway, thereby achieving anticoagulant/antithrombotic effects. Preclinical trial data show that a single subcutaneous injection of SRSD107 can achieve nearly 100% knockdown of FXI expression, lasting up to half a year, with no bleeding observed. SRSD107 combines potent, long-lasting efficacy with excellent safety and has the potential to become a first-in-class and best-in-class next-generation safer anticoagulant drug.

About Sirius Therapeutics

Sirius Therapeutics is an innovative biotechnology company dedicated to advancing human health and well-being. Focused on the development of next-generation nucleic acid therapies for cardiovascular diseases, it strives to become a leader in revolutionizing the prevention and treatment of chronic conditions.

Founded in 2021, Sirius Therapeutics was incubated by an internationally renowned management team and globally recognized healthcare investment institutions. The company adopts an international strategic positioning, leveraging the talent and resource advantages in the field of small nucleic acid therapies from both the United States and China. It has established a layout with the U.S. as the source of innovative discovery center and China as the global translational medicine center. Utilizing its core technology platform for small nucleic acid drug development, we have developed multiple product pipelines with differentiated global competitive advantages, possessing first-in-class or best-in-class potential. In October 2023, the company completed a $60 million Series B financing round, bringing the total funding to nearly $100 million.

References:
[1]LozanoR,NaghaviM,ForemanK,etal.Lancet.2012;380,2095-1128.

Editor: Bai Ji

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