Argo Biopharma Doses First Participant in Phase I Clinical Trial of Factor XI Targeting siRNA Therapy BW-41012

BW-41012 represents the eighth clinical candidate from Argo's innovative RNAi pipeline, and is being evaluated for the prevention of thromboembolic diseases

SHANGHAI and NEW YORK, July 20, 2026 /PRNewswire/ -- Argo Biopharmaceutical Co., Ltd. (Argo Biopharma), a clinical-stage small interfering RNA (siRNA) therapeutics company, today announced the first participant has been dosed in its Phase I study of BW-41012, an investigational siRNA therapy targeting factor XI (FXI) for the prevention of thromboembolic diseases. In addition, the company received Investigational New Drug (IND) approval from the China National Medical Products Administration (NMPA) this month for BW-41012, further advancing its global clinical development.

"Dosing the first participant in this Phase 1 study represents another important step in advancing our RNAi pipeline and progressing our innovative therapeutic approaches for thromboembolic diseases, an areas of high unmet need. We believe that by targeting FXI, BW-41012 has potential in thromboembolic diseases, including deep vein thrombosis, pulmonary embolism, and ischemic stroke. We are advancing a global clinical program to evaluate its potential, and look forward to providing updates as our clinical trials progress," said Dr. Dongxu Shu, Co-founder and CEO of Argo Biopharma.

BW-41012 is an siRNA therapeutic that targets FXI mRNA. The Phase I study is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous administration of BW-41012 in healthy volunteers in Australia. The study will assess safety and biomarkers of biological activity, including clinical laboratory parameters, vital signs, electrocardiogram (ECG) measurements, FXI activity, and FXI antigen levels, to characterize the pharmacological profile of BW-41012 and support its further clinical development for the treatment of thromboembolic diseases.

About Thromboembolic Diseases

Thromboembolic diseases are caused by the formation of blood clots that block blood vessels, leading to serious and potentially life-threatening complications. They include conditions such as deep vein thrombosis (DVT), pulmonary embolism (PE), ischemic stroke, and other thrombotic disorders. Although current anticoagulants are effective in reducing thrombotic events, their use is often limited by an increased risk of bleeding. FXI has emerged as a promising therapeutic target, with the potential to provide effective antithrombotic protection while minimizing bleeding risk.

About Argo Biopharma

Argo Biopharma is a clinical-stage biotechnology company committed to developing next-generation RNAi therapeutics to provide better treatment options for patients worldwide. The company has established a robust and diverse pipeline of RNAi molecule candidates targeting a wide range of indications, including cardiovascular diseases, viral infections, metabolic conditions, and specialty/rare diseases. Currently, Argo Biopharma has eight RNAi candidates in clinical development.

For more information, please visit www.argobiopharma.com.

SOURCE Argo Biopharmaceutical Co., Ltd