Sirius Completes Enrollment in Phase 1 Trial of a PCSK9 siRNA

March 22nd, 2024

March 22nd, 2024, San Diego and Shanghai - Sirius Therapeutics today announced the completion of subject enrollment of the Phase 1 study of SRSD101, a novel siRNA therapeutics targeting PCSK9 for treatment of Dyslipidemia. This Phase I study is to evaluate SRSD101 safety, tolerability, pharmacokinetics and pharmacodynamics at single ascending doses. 


"The enrollment of SRSD101 phase 1 study was completed with less than four months since its IND approval, demonstrating Sirius’ translational capability of clinical development. This milestone couldn't have been achieved without strong support by the participants of SRSD101, physicians of the study, Sirius’ team as well as our partners. We look forward to further advancing SRSD101 development and ultimately providing new treatment option for cardiovascular disease patients soon. " said Dr. Qunsheng Ji, Sirius Therapeutics Chief Executive Officer.


About Cardiovascular Diseases

Cardiovascular disease (CVD) is the leading cause of death worldwide, resulting in over 17 million deaths annually [1]. Elevated low-density lipoprotein cholesterol (LDL-C) is a major risk factor for the development of CVD. For every 1 mmol/L (38.7 mg/dL) change in LDL-C, the relative risk for CVD increase by more than 20% [2].


Statins, the backbones of lowering LDL-C, are the primary and secondary prevention of CVDs. However, due to statins’ poor adherence and/or intolerance, about 50% of patients failed achieving the guideline-recommended LDL-C target levels [3,4].


About SRSD101

SRSD101 is a novel double-stranded small interfering ribonucleic acid (siRNA). Developed by Sirius Therapeutics, SRSD101 specifically targets Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) mRNA to inhibit PCSK9 protein production, and subsequently increases LDL-C receptors, thereby lowing LDL-C in the circulation. The pronounced durability of pharmacology and safety profile exhibited in preclinical studies suggested SRSD101 has potential to be a new-generation therapeutic for dyslipidemia.


About Sirius Therapeutics

Sirius is an innovative biotech company developing next generation siRNA therapy for global markets. We are dedicated to discovering and developing new treatment options for cardiovascular disease patients.


Founded in 2021 by a world-class leadership team and investors, Sirius has established an innovative discovery center in the United States and translational medicine center in China. Sirius has raised nearly US$100 million funding to date. For more information, please visit to the website



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

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).

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