Sirius Therapeutics Announces Completion of Phase I Clinical Trial Enrollment for Its Investigational PCSK9-Targeting siRNA Drug SRSD101

Dr. Jiqunsheng

Chief Executive Officer and Executive Director of Sirius Therapeutics

Cardiovascular disease (CVD) is the leading killer of human health, with more than 17 million people dying from cardiovascular disease each year.^[1]. Elevated low-density lipoprotein cholesterol (LDL-C) is a major risk factor for the development of cardiovascular disease. For every 1 mmol/L (38.7 mg/dL) change in LDL-C, the relative risk of cardiovascular disease increases by more than 20%. ^[2]。

Although statins are the cornerstone for reducing LDL-C and for the primary and secondary prevention of acute atherosclerotic cardiovascular disease (ASCVD), about 50% of patients currently do not achieve their LDL-C goals due to statin intolerance and poor medication adherence.^[3,4]。

SRSD101 Injection is a double-stranded small interfering nucleic acid (siRNA) drug independently developed by Sirius Therapeutics. It specifically targets the mRNA of proprotein convertase subtilisin/kexin type 9 (PCSK9) in the liver, blocking PCSK9 protein synthesis, thereby enhancing the ability of hepatocytes to uptake LDL-C to achieve lipid-lowering effects. Preclinical trial data show that SRSD101 has both potent and long-lasting lipid-lowering efficacy and good safety, with the potential to become a new generation of lipid-lowering product.

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 transforming the prevention and treatment of chronic conditions.

Founded in 2021, Sirius Therapeutics was incubated by an internationally renowned management team and globally acclaimed healthcare investment institutions. The company adopts an international strategic positioning, leveraging the talent and resource advantages of both the United States and China in the field of small nucleic acid therapeutics. It has established a research and development center for innovative source technologies in the U.S. and a global translational medicine center in China. Utilizing its core technology platform for small nucleic acid drug development, the company has built a diversified pipeline with multiple products possessing first-in-class and best-in-class potential and a competitive edge on a global scale. To date, the company has raised nearly 100 million U.S. dollars in cumulative financing.

Reference:

1. Cardiovascular diseases (CVDs) - World Health Organization (WHO).

https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-%28cvds%29.

2. Sabatine, Marc S., et al. Efficacy and Safety of Further Lowering of Low-Density Lipoprotein Cholesterol in Patients Starting With Very Low Levels: A Meta-analysis. JAMA Cardiol. 2018 Sep 1;3(9):823-828.

3. Mann DM, Woodward M, Muntner P, Falzon L, and Kronish I. Mann Predictors of Nonadherence to Statins: A Systematic Review and Meta-Analysis. Ann Pharmacother. 2010;44:1410-21.

4. Poluzzi, E., Strahinja, P., Lanzoni, M. et al. Adherence to statin therapy and patients’ cardiovascular risk: a pharmacoepidemiological study in Italy. Eur J Clin Pharmacol 64, 425–432 (2008).