Sirius Therapeutics Submits First-in-Human Clinical Trial Application in Australia for Novel Long-Acting FXI-Targeting siRNA Anticoagulant SRSD107

Shanghai, China and San Diego, USA, November 10, 2023: Sirius Therapeutics (SHANGHAI) Co., Ltd. ("Sirius Therapeutics"), announced today that its first self-developed small nucleic acid drug (SRSD107 injection) has officially submitted its first-in-human (FIH) clinical trial application in Australia. SRSD107 is a novel anticoagulant used for the prevention or treatment of thromboembolic diseases. The clinical submission of SRSD107 marks a significant milestone for Sirius Therapeutics as it transitions from early drug research to clinical development.

"SRSD107 has demonstrated excellent pharmacological and safety characteristics, with the potential to become a dosing regimen administered every six months or annually. It is expected to be a transformative therapy in anticoagulation treatment. We remain committed to the development of next-generation siRNA innovative therapies to meet clinical needs and benefit patients worldwide." Dr. Ji Qunsheng, CEO and Executive Director of Sirius Therapeutics

1. Regarding Thromboembolism

Thrombosis, a blood clot that restricts blood flow within blood vessels, can occur in either arterial or venous circulation and serves as 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.

2. About SRSD107 Injection

SRSD107 Injection is a double-stranded small interfering ribonucleic acid (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 FX protein expression, blocking 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 and 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 outstanding management team and globally renowned healthcare investment institutions. The company adopts an international strategic positioning, leveraging the talent and resource advantages in the field of small nucleic acid therapy 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, the company has developed multiple product pipelines with either first-in-class or best-in-class potential, showcasing differentiated global competitive advantages. In October 2023, the company completed a $60 million Series B financing round, bringing its total funding to nearly $100 million.

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

Editor: Baiji

Disclaimer: This article is a reprint from Pharma Intelligence Network. The images and text are the original works of the author, and the purpose of the reprint is to convey more information. It does not represent the views of this platform. If there are any issues regarding the content, copyright, or other aspects, please leave a message on this platform, and we will address it promptly.