Sirius Therapeutics Submits IND Application to NMPA for Another Novel siRNA Therapy

Dec. 31^st, 2024, San Diego and Shanghai - Sirius Therapeutics today announces that its submission of Investigational New Drug (IND) application for SRSD216, a novel siRNA therapeutic for the management of Hyperlipoproteinemia(a), is accepted by National Medical Products Administration (NMPA).

"This submission marks a significant milestone in the development of our innovative siRNA therapies. Numerous genetic and epidemiologic studies have demonstrated an association between elevated levels of lipoprotein(a) and atherosclerotic cardiovascular disease. The exceptional durability of the pharmacodynamic effects and the benign safety profile in preclinical studies suggests that SRSD216 could represent a substantial step forward in the prevention of ASCVD. We are committed to advancing this promising treatment into phase 1 clinical trials and beyond." said Dr. Patrick Yue, Chief Medical Officer.

"We are excited to reach this critical step in the development of SRSD216," said Dr. Qunsheng Ji, Chief Executive Officer. "our team has worked diligently to achieve this milestone as a part of Sirius’ broader strategy to develop innovative treatments for cardiometabolic diseases."

For more information on the study and our ongoing clinical trials, please visit Sirius Therapeutics' website (www.siriusrna.com).

About ASCVD and hyperlipoproteinemia(a)

Atherosclerotic cardiovascular disease (ASCVD) is the most common cause of death worldwide. Dyslipidemia is regarded as a key contributor to the development of ASCVD. While low-density lipoprotein cholesterol (LDL-c) has been considered the primary lipid indicator and target for intervention for decades, numerous studies have identified lipoprotein(a) [Lp(a)] as an independent risk factor for ASCVD. Moreover, Lp(a) is not modified by age, diet, or exercise and currently available pharmacotherapies for dyslipidemia have only modest effects on Lp(a), highlighting a significant clinical unmet need for agents that directly target Lp(a).

About SRSD216

SRSD216 is a novel double-stranded small interfering ribonucleic acid (siRNA) that specifically modulates the LPA gene, decreasing hepatic Apo(a) production and reducing circulating Lp(a) levels. Preclinical in vivo studies have demonstrated a near 100% reduction in Lp(a) levels over 6 months, with no meaningful safety findings reported after a single subcutaneous dose.

About Sirius Therapeutics

Sirius is a clinical stage biotech company developing innovative siRNA therapies for global markets. We are dedicated to discovering and developing new treatment options for cardiovascular disease and translating siRNA technology into transformative medicine for chronic disease patients. Our most advanced products are SRSD107 for the treatment of thromboembolic disorders, and SRSD101 for the treatment of dyslipidemia. 

Founded in 2021 by a world-class leadership team and investors, Sirius has established an innovation center in the United States and translational medicine center in China. Sirius has raised nearly US$100 million funding to date from OrbiMed, Creacion Ventures, Hankang Capital, and Delos Capital.