Sirius Therapeutics Announces CDE Acceptance of IND Application for SRSD216, a Novel siRNA Therapy Targeting Lipoprotein(a) in China
Sirius Therapeutics
Oligonucleotide Drug Developer
December 31, 2024, Shanghai, China, and San Diego, USA: Sirius Therapeutics (SHANGHAI) Co., Ltd. ("Sirius Therapeutics"), today announced that the clinical trial application (IND) for SRSD216 has been successfully accepted by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration. SRSD216 is a next-generation siRNA therapy for the treatment of hyperlipoproteinemia(a).Hankang Capital led the Series B financing of Sirius Therapeutics in 2023.
"This submission marks an important milestone in the development of Sirius Therapeutics' innovative siRNA therapy. The association between elevated lipoprotein(a) levels and atherosclerotic cardiovascular disease has been supported by numerous genetic and epidemiological studies. Preclinical data indicate that SRSD216 exhibits excellent and sustained pharmacodynamic characteristics along with a favorable safety profile, offering a promising new solution for the prevention of cardiovascular diseases. We will fully advance the clinical development of this highly promising therapy."Dr. Peichuan Yu, Chief Medical Officer of Sirius TherapeuticsRepresentation.
"We are delighted to reach this crucial step in the development of SRSD216."Dr. Qunsheng Ji, CEO of Sirius Therapeutics"This is the result of our team's joint efforts, and another important step forward in Sirius Therapeutics’ comprehensive strategy to develop innovative therapies for cardiometabolic diseases."
AboutASCVDHyperlipoproteinemia(a)
Atherosclerotic cardiovascular disease (ASCVD) is the most common cause of death worldwide. Dyslipidemia is considered a key factor in the development of ASCVD. DespiteLow-Density Lipoprotein Cholesterol(LDL-C) has long been regarded as the primary lipid indicator and intervention target for ASCVD. However, numerous studies have shown that lipoprotein(a) [Lp(a)] is an independent risk factor for ASCVD and is 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).
AboutSRSD216 Injection
SRSD216 Injection is a novel double-stranded small interfering ribonucleic acid (siRNA). It specifically modulatesLPAGenes reduce liver Apo(a) production and lower Lp(a) levels in circulation. Preclinical in vivo studies have shown that a single dose reduces 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 for thromboembolic disorders and SRSD101 for dyslipidemia, both of which have entered the clinical development stage.
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 differentiated global competitive advantages, possessing first-in-class or best-in-class potential. Sirius Therapeutics has cumulatively secured nearly 100 million U.S. dollars in financing.
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