Sirius Therapeutics Announces Promising Phase I Clinical Data from Its Factor XI siRNA, a Long-Acting Next-Generation Anticoagulant for Thromboembolic Disorders
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
Andersen Consulting udvider sit udbud med LBC12.12.2025 11:09:00 CET | Pressemeddelelse
Andersen Consulting styrker sine kompetencer gennem en samarbejdsaftale med LBC, en Portugal-baseret international virksomhed kendt for sin integrerede tilgang til forretningsoptimering, digital transformation og udvikling af menneskelig kapital, der kombinerer kreativitet og menneskelig etik med ai med henblik på at accelerere værdiskabelse. LBC blev stiftet i 2001 og bistår internationale organisationer, offentlige instanser og virksomheder inden for adskillige brancher, herunder finans, energi, TMT, transport og den offentlige sektor. LBC betjener kunder i Afrika, Nord- og Sydamerika samt Europa og leverer ydelser inden for management consulting, digital transformation, kapacitetsopbygning og ai-implementering. Virksomheden er kendt for en kultur præget af innovativ transformation med fokus på vedvarende resultater og hjælper kunder med at navigere i komplekse forandringer med målbar effekt. Nylige investeringer i enterprise AI styrker virksomhedens kompetencer inden for UX/UI, auto
INNIO to Supply Technology for a Landmark Project in Texas, Reinforcing Grid Stability12.12.2025 09:59:00 CET | Press release
INNIO Group, a leading energy solution and service provider, is collaborating with the U.S. power utility Greenville Electric Utility System (GEUS) on a landmark 104-megawatt (MW) power plant. The new plant is designed to help reinforce grid stability, cover peak loads, and enable greater integration of renewable energy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251211712708/en/ Jenbacher J920 FleXtra “This project is a milestone for Texas and for INNIO. With fast-start capability, flexibility, and sustainability, we are creating the energy infrastructure that modern grids need: reliable, growth-promoting, and supporting the expansion of renewables,” said Dr. Olaf Berlien, President and CEO of INNIO Group. Groundbreaking for the plant’s construction took place in early December, with commissioning scheduled for summer 2027. The groundbreaking marks the beginning of the largest installation to date of Jenbacher J920 FleX
Kioxia Develops Core Technology that Will Allow the Practical Implementation of High-density, Low-power 3D DRAM12.12.2025 06:24:00 CET | Press release
Showcase the technology of highly stackable oxide-semiconductor channel transistors Kioxia Corporation, a world leader in memory solutions, today announced the development of highly stackable oxide-semiconductor channel transistors that will enable the practical implementation of high-density, low-power 3D DRAM. This technology was presented at the IEEE International Electron Devices Meeting (IEDM) held in San Francisco, USA, on December 10, and has the potential to reduce power consumption across a wide range of applications, including AI servers and IoT components. In the era of AI, there is growing demand for DRAM with larger capacity and lower power consumption that can process large amounts of data. Traditional DRAM technology is reaching the physical limits of memory cell size scaling, prompting research into the 3D stacking of memory cells to provide additional capacity. The use of single-crystal silicon as the channel material for transistors in stacked memory cells, as is the
Andersen Global styrker sine juridiske kapaciteter med tilføjelsen af brasiliansk medlemsfirma11.12.2025 18:49:00 CET | Pressemeddelelse
Andersen Global udbygger sin juridiske platform i Brasilien, da Lotti e Araújo bliver et medlemsfirma, hvilket styrker organisationens kapacitet i Latinamerika. Lotti e Araújo blev stiftet for over 20 år siden og tilbyder omfattende juridisk rådgivning til brasilianske og multinationale klienter inden for en lang række brancher. Dets tværfaglige praksis omfatter selskabsret, skatteret, arbejdsret, retssager, inkasso og inddrivelse af gæld – samt specialiseret arbejde med at identificere skjulte aktiver og inddrive anke- og retsindskud i ældre sager. Firmaet håndterer også voldgift, forvaltningsret, udenlandske investeringer, fast ejendom, intellektuel ejendomsret, databeskyttelse og virksomhedsomstrukturering og tilbyder juridisk assistance inden for selskabsdannelse og repræsentation over for tilsynsmyndigheder. Teamet rådgiver klienter om forebyggende juridiske strategier og komplekse tvister for administrative organer og domstole i Brasilien. "Hos Lotti e Araújo bygger vores praksis
BEYOND Developments Reveals a New Vision for Purposeful Living on Dubai Islands with SIORA11.12.2025 18:02:00 CET | Press release
A 2M sqft masterplan inspired by Japanese garden principles, crafted around balance, clarity, and the quiet rhythm of coastal life BEYOND Developments, the bold and design-led real estate developer shaping next-generation waterfront destinations in the UAE, today unveiled SIORA, its first beachfront masterplan on Dubai Islands and the company’s second large-scale community within a year. The launch underscores BEYOND’s accelerated growth and strong alignment with Dubai’s future urban vision. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251211014389/en/ BEYOND Developments - SIORA Masterplan at sunset - Dubai Islands (Photo: AETOSWire) Spanning over 2M square feet, SIORA is conceived as a coastal sanctuary inspired by Japanese garden philosophies, including the pursuit of Ikigai, the Japanese concept of finding purpose and fulfilment in everyday life. In this context, it reflects a philosophy of creating spaces that bring c
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