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
Crown Bioscience Expands US Presence with New Model Development Center in Kannapolis, North Carolina17.9.2025 14:30:00 CEST | Press release
Crown Bioscience, a global contract research organization (CRO) headquartered in the United States and part of JSR Life Sciences and Japan-based JSR Corporation, today announced the opening of a state-of-the-art model development center in Kannapolis, North Carolina. This strategic investment expands the company’s operations and enhances its ability to deliver advanced preclinical oncology models, including patient-derived xenografts (PDX), PDX warm models, PDX-derived organoids (PDXO), and patient-derived organoids (PDO), to meet the evolving needs of pharmaceutical and biotechnology companies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250917864004/en/ Crown Bioscience celebrate the official ribbon-cutting ceremony for the company’s new Kannapolis, North Carolina facility, marking an expansion of US oncology model development and preclinical CRO services. The new facility strengthens Crown Bioscience’s US-based capabil
SBC Medical Accelerates Multi-Brand Strategy with Hybrid Dermatology Model “Hada no Aozora Clinic” Establishment17.9.2025 14:00:00 CEST | Press release
SBC Medical Group Holdings Incorporated (Nasdaq: SBC) (“SBC Medical”), a global provider of comprehensive consulting and management services to the medical corporations and their clinics, today announced the launch of a new brand, “Hada no Aozora Clinic”, scheduled to open in Tokyo on October 1, 2025. This clinic will adopt a hybrid dermatology model that integrates insurance-covered general dermatology and private-pay aesthetic treatments, advancing SBC’s multi-brand strategy in the rapidly expanding aesthetic medicine market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250917897380/en/ SBC Medical Accelerates Multi-Brand Strategy with Hybrid Dermatology Model “Hada no Aozora Clinic” Establishment As life expectancy continues to rise and demographic aging accelerates, more people are seeking treatments that help them maintain both well-being and a youthful appearance over a longer lifespan. Within this environment, aesth
Rubedo Life Sciences Announces U.S. FDA Clearance of IND for Selective GPX4 Modulating Lead Drug Candidate RLS-1496 for Actinic Keratosis, Expands Clinical Advisory Board17.9.2025 14:00:00 CEST | Press release
IND clearance marks second study accepted for RLS-1496, a first-in-class disease-modifying selective GPX4 modulator targeting pathological senescent cells that drive inflammaging and chronic degenerative diseases and conditions associated with the biological aging process through ferroptosis Results from first RLS-1496 study in patients with psoriasis, atopic dermatitis, and skin aging are expected in Q4 2025; the actinic keratosis Phase 1b/2a study will begin in Q4 2025 Rubedo Clinical Advisory Board expands to include globally renowned dermatologist and immunologist Emma Guttman-Yassky, MD, PhD., Waldman Professor of Dermatology and Immunology and Health System Chair of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai Rubedo Life Sciences, Inc. (Rubedo), an AI-driven, clinical-stage biotech focused on discovering and rapidly developing selective cellular rejuvenation medicines targeting aging cells, today announced that the U.S
New Study Finds That Using Masimo Technologies to Continuously Monitor General Floor Patients Reduces Costs17.9.2025 14:00:00 CEST | Press release
Universal Surveillance Monitoring with Masimo SET® Pulse Oximetry and Patient SafetyNet™ – Repeatedly Shown to Improve Patient Outcomes and Save Lives – Also Projected to Yield Significant Cost Savings Masimo (NASDAQ: MASI) today announced the findings of a study published in the Journal of Patient Safety in which Dr. George Blike and colleagues at Dartmouth-Hitchcock Medical Center in New Hampshire demonstrated that use of Masimo technologies to continuously monitor general floor patients can yield significant cost savings.1 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250917266545/en/ Continuous Patient Monitoring with Masimo SET® Pulse Oximetry and Patient SafetyNet™ In prior studies, the clinical outcome benefits of continuously monitoring patients using Masimo SET® and Patient SafetyNet™ have been shown to include lower mortality, improved resuscitative outcomes, and fewer rapid response team activations and transfers
Merck to Present New Data Highlighting Durable Effects of MAVENCLAD® in Relapsing Multiple Sclerosis (RMS) at ECTRIMS 202517.9.2025 14:00:00 CEST | Press release
Four-year data show nearly 9 in 10 RMS patients remained free from progression independent of relapse activity (PIRA)Results highlight the potential of MAVENCLAD to reduce neurodegeneration and neuroinflammation beyond established clinical efficacy outcomes in RMSEvidence suggests that MAVENCLAD effectiveness could be driven by peripheral and central effects without requiring continuous immunosuppression Not intended for UK-, US- or Canada-based media Merck, a leading science and technology company, today announced the presentation of over 30 abstracts from its multiple sclerosis (MS) portfolio. New four-year data from two large Phase 4 studies highlight the long-term efficacy, favorable disability outcomes and durable impact of MAVENCLAD® (cladribine tablets) in people living with relapsing multiple sclerosis (RMS). These findings are to be presented at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), being held September 24-26 in
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