Argo Biopharmaceutical has announced the first participant has been dosed in its phase 1 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.

Dr. Dongxu Shu, Co-Founder and CEO, Argo Biopharma, said, "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."

BW-41012 is a siRNA therapeutic that targets FXI mRNA. The phase I study is a randomised, 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 characterise the pharmacological profile of BW-41012 and support its further clinical development for the treatment of thromboembolic diseases.