Sirius Therapeutics Announces FDA Clearance of IND for SRSD216, a Novel siRNA Therapy Targeting Lipoprotein(a) to Address Unmet Needs in ASCVD
Sirius Therapeutics
Oligonucleotide Drug Developer
On April 9, 2025, Sirius Therapeutics announced that the U.S. Food and Drug Administration (FDA) had approved the Investigational New Drug (IND) application for its new drug SRSD216, allowing clinical trials to proceed. This significant milestone marks another crucial step by Sirius Therapeutics in addressing the unmet medical needs of patients with atherosclerotic cardiovascular disease (ASCVD) globally. Notably, the Phase I clinical trial of this product in China completed the dosing of its first subject on April 8.
Numerous genetic and epidemiological studies have demonstrated a close association between elevated lipoprotein(a) levels and atherosclerotic cardiovascular disease (ASCVD). SRSD216 has exhibited significant and durable pharmacodynamic effects as well as favorable safety profiles in preclinical studies, indicating that this novel siRNA therapy holds great promise for the prevention of ASCVD.
Curt Bradshaw, Ph.D., Chief Scientific Officer of Sirius Therapeutics, stated"SRSD216 is an siRNA therapy developed based on our self-innovative technology platform, with the advantage of a dosing interval of every six months or longer, making it more suitable for the management and prevention of chronic diseases. Since the establishment of Sirius Therapeutics in 2021, SRSD216 has become the third product to successfully enter the clinical development stage, strongly validating the powerful capabilities of our platform in the discovery and development of advanced siRNA therapies, and demonstrating tremendous potential for continuous innovation."
Dr. Qunsheng Ji, CEO of Sirius Therapeutics, added"We are actively advancing the global R&D process of SRSD216. The Phase I clinical trial conducted in the United States is not only a key step in the global development of SRSD216 but also an essential part of Sirius Therapeutics' overall strategy to establish advanced therapies for cardiometabolic diseases."Currently, the Chinese part of the Phase I clinical trial for this product has been initiated first. It took less than three weeks from receiving clinical approval to administering the first dose to the initial subject. Our heartfelt thanks go to the research center, the Sirius Therapeutics team, and external collaborators for their support and cooperation."
|About ASCVD and Hyperlipoproteinemia(a)|
Atherosclerotic cardiovascular disease (ASCVD) is the most common cause of death worldwide. Dyslipidemia is considered a key factor in the development of ASCVD. Although low-density lipoprotein cholesterol (LDL-C) has always been regarded as the primary lipid indicator and intervention target for ASCVD, numerous studies have shown that lipoprotein(a) [Lp(a)] is an independent risk factor for ASCVD, unaffected by age, diet, or exercise. Currently available lipid-lowering drugs have limited efficacy in reducing Lp(a). Therefore, there is a significant unmet clinical need for drugs that directly target Lp(a).
|About SRSD216 Injection|
SRSD216 Injection is a novel double-stranded small interfering ribonucleic acid (siRNA). It specifically modulates the LPA gene, reducing hepatic Apo(a) production and lowering circulating Lp(a) levels. Preclinical in vivo studies have shown that a single dose reduced Lp(a) levels by nearly 100%, with effects lasting over six months, and no significant safety events were observed.
|About Sirius Therapeutics|
Sirius Therapeutics is a clinical-stage biotechnology company dedicated to advancing human health and well-being. Focused on the global development of next-generation nucleic acid therapies for cardiometabolic diseases, the company aims to become a leader in transforming the prevention and treatment of chronic conditions. Its current pipeline includes SRSD107, which has entered clinical development for thromboembolic disorders, and SRSD101 for dyslipidemia.
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 therapies from both the United States and China. It has established a layout with the U.S. as the source innovation center and China as the global translational medicine center. Utilizing its core technology platform for small nucleic acid drug research and development, the company has developed multiple product pipelines with first-in-class or best-in-class potential and differentiated global competitive advantages. Sirius Therapeutics has cumulatively secured nearly 100 million U.S. dollars in financing from OrbiMed, Hongyuan Capital, H&Q Healthcare Capital, and Prosperity Investment.
E.N.D
'%20fill='%23FFFFFF'%3E%3Crect%20x='249'%20y='126'%20width='1'%20height='1'%3E%3C/rect%3E%3C/g%3E%3C/g%3E%3C/svg%3E)
Article Recommendation (Click on the article title below to open the original):
For autoimmune diseases, an mRNA CAR-T cell drug is about to enter Phase III clinical trials
Construction of a GMP Facility for Cell Drug Production in China Officially Begins
$1.4 Billion! Lilly Makes a Big Bet on AAV Gene Therapy
A Cell Therapy Company in China Completes Pre-A Round Financing
A Gene Drug Company in China Completes New Round of Financing
$500 Million! WuXi Biologics Completes a Deal
China's First Solid Tumor Cell Drug Marketing Application Accepted
An RNA Drug Approved for Marketing