Sirius Therapeutics Announces Promising Phase I Clinical Data from Its Factor XI siRNA, a Long-Acting Next-Generation Anticoagulant for Thromboembolic Disorders
10.12.2024 05:00:00 CET | Business Wire | Press release
Data presented at American Society of Hematology annual meeting
Sirius Therapeutics today announced promising preliminary data from its Phase 1 first-in-human clinical trial of SRSD107, a next generation siRNA therapeutics under clinical development for the prevention and treatment of thromboembolic disorders, such as myocardial infarction, ischemic stroke, and venous thromboembolism. The trial data were presented during a poster session at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, held in San Diego, CA.
SRSD107 is designed to inhibit Factor XI (FXI), a protein in the coagulation pathway that has shown potential to reduce thrombosis without significantly increasing the risk of bleeding, a major liability of current drugs.
“In this trial, SRSD107 was safe and well tolerated, with pharmacokinetic parameters consistent with a typical siRNA product,” said Dr. Patrick Yue, Sirius’ Chief Medical Officer. “We are encouraged by the marked, prolonged reduction in FXI antigen and activity, and increase in clotting, or thromboplastin time, that are consistent potent anticoagulation over sustained periods and reduced bleeding risk respectively. The trial provides a strong foundation for Phase 2 clinical studies.”
Dr. Qunsheng Ji, Sirius’ Chief Executive Officer added that “presentation of these findings at ASH 2024 underscores Sirius Therapeutics' commitment to advancing innovative treatments for thromboembolic disorders.”
The study was a single-site, randomized double-blind, placebo controlled study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of subcutaneously administered SRSD107 in 40 healthy subjects. Five cohorts, each consisting of eight subjects evaluated eight doses of SRSD107, each receiving either a single SRSD107 dose or placebo. In the trial, SRSD107 was safe and well-tolerated. Significant changes from baseline in PD biomarkers were observed, with maximal reductions in FXI antigen and activity > 90% and an aPTT (thromboplastin time) increase of > 100% (i.e., an aPTT ratio > 2.0) at the highest doses tested. The pharmacodynamic effects were durable, with FXI antigen and activity levels remaining suppressed for more than 16 weeks after dosing.
The study is titled, “A Phase 1, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered SRSD107 in Healthy Subjects. For more information on the study and our ongoing clinical trials, please visit Sirius Therapeutics' website (www.siriusrna.com) or here.
About Thromboembolic Disorders
Thrombosis, or blood clot formation, is the common underlying mechanism of most cases of myocardial infarction, ischemic stroke, and venous thromboembolism. According to a study in The Lancet of regional and global mortality rates, thromboembolic disorders are estimated to cause as many as 1 in 4 deaths worldwide.
About SRSD107
SRSD107 is a novel double-stranded small interfering ribonucleic acid (siRNA). Developed by Sirius Therapeutics, SRSD107 specifically targets human coagulation factor XI (FXI) mRNA and inhibits FXI protein expression, thereby blocking the intrinsic coagulation pathway and promoting anticoagulant/anti-thrombotic effects. SRSD107 has been engineered for the potential to enable once or twice-a-year dosing.
About Sirius Therapeutics
Sirius is an innovative, clinical stage biotech company developing next generation siRNA therapy for global markets. We are dedicated to translating siRNA technology into transformative medicine for patients with chronic diseases. 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 innovative discovery 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, Delos Capital, and the leadership team.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241209815845/en/
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Alipay Launches Next-Generation AI Payment Infrastructure, Debuts AI Wallet and Token Pay to Power Agentic Economy26.5.2026 17:20:00 CEST | Press release
Alipay today introduced its full-stack AI payment solution to partners across industries, ranging from AI companies to traditional retailers, and debuted two new services — the world’s first AI Wallet and Token Pay — to support the agentic economy’s rapid growth. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260526337824/en/ Alipay Unveils Next-generation AI Payment Infrastructure This launch extends Alipay's next-generation AI payment infrastructure, building on its consumer-facing product Alipay AI Pay and its business-facing AI payment processing product. “While the essence of commerce remains unchanged in the age of AI, the emergence of AI agents is reshaping everything. Drawing on 22 years of technological expertise and commercial know-how, Alipay is building a new generation of AI payment services to accelerate the growth of the agentic commerce ecosystem,” said Cyril Han, CEO of Ant Group. AI Wallet: Giving Users Vis
Daiichi Sankyo Europe Reaffirms Commitment to Patient-Centred Care with Extensive Data Showcase at EAS Congress 202626.5.2026 17:00:00 CEST | Press release
Presentations at the 94th European Atherosclerosis Society (EAS) Congress highlight the breadth of evidence for bempedoic acid across a wide range of patient subgroups and background therapies. Real-world data from the MILOS study across multiple European cohorts demonstrate consistent effectiveness and safety profile in routine clinical practice.1,2,3,4 Analysis from the CLEAR Outcomes trial underscores the impact of bempedoic acid on cardiovascular risks, including stroke and venous thromboembolism (VTE).5,6 Daiichi Sankyo Europe’s commitment to "care for every heartbeat" is centred on providing accessible oral treatment options to ensure every patient is given a chance to reach their LDL-C goals. Daiichi Sankyo Europe (DSE) is pleased to announce its extensive scientific presence at the European Atherosclerosis Society (EAS) Congress 2026. The presentation of 15 abstracts, comprising both clinical trial analyses and real-world evidence, underscores the company's sustained investment
OpenRouter Raises $113 Million CapitalG-led Series B as Weekly Volume Explodes to 25T Tokens26.5.2026 15:15:00 CEST | Press release
NVentures, ServiceNow Ventures, MongoDB Ventures, Snowflake Ventures, Databricks Ventures join CapitalG, a16z, Menlo Ventures, and others in backing the high-growth AI infrastructure startup OpenRouter, the AI model exchange, today announced a $113 million Series B led by Alphabet’s independent growth fund, CapitalG, with participation from investors including NVentures (NVIDIA’s venture capital arm), ServiceNow Ventures, MongoDB Ventures, Snowflake Ventures, Databricks Ventures, alongside existing investors including Andreessen Horowitz and Menlo Ventures. OpenRouter’s volume has surged to 25 trillion tokens per week (100 trillion tokens per month), representing a 5X increase from the 5 trillion tokens processed per week just six months ago. The explosion in token demand illustrates how quickly enterprises are deploying agents and scaling AI across multiple models and providers. OpenRouter’s infrastructure manages and optimizes inference and provides access to 400+ models across leadi
Xsolla Expands Its Community Management Tools for Creators, Community Leaders, and Resellers26.5.2026 15:00:00 CEST | Press release
Xsolla Adds New Features For Creators, Community Leader Experience, And Distinct Channels For Emerging Markets Xsolla, a leading global video game commerce company, today announced three simultaneous expansions of its community management tools and products. As the creator economy continues to reshape how games are discovered and the industry accelerates its shift toward direct-to-consumer commerce, Xsolla is building on its community management tools for creators, community leaders, and emerging markets, and will showcase them at TwitchCon Rotterdam later this month. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260526596720/en/ Graphic: Xsolla The games industry has never had a shortage of people who drive player acquisition, loyalty, and commerce; it's had a shortage of infrastructure that recognizes them. Creators stream it. Community leaders build a culture around it. Local resellers get it into the hands of players in
Biocytogen Launches AI-Powered RenSuper™ Platform and Industry-First Fully Automated Antibody Discovery Infrastructure26.5.2026 14:00:00 CEST | Press release
Biocytogen today announced the launch of RenSuper Workstation, a next-generation AI-powered antibody discovery platform providing off-the-shelf access to a large-scale, experimentally validated library of fully human therapeutic antibody sequences, together with the RenSuper High-Throughput Antibody Manufacturing Automation Center, a fully automated infrastructure designed to accelerate antibody validation and production. Built on Biocytogen’s proprietary RenMice® platforms, RenSuper establishes a closed-loop antibody discovery engine combining in vivo immune repertoires, AI-driven candidate selection, automated experimental validation, and scalable manufacturing infrastructure. The platform supports the discovery and development of monoclonal antibodies, bispecifics, multispecifics, antibody-drug conjugates (ADCs), VHHs, and other advanced therapeutic modalities, significantly reducing the time and risk associated with antibody discovery. RenSuper Workstation: AI-Powered One-Click Tar
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom