The clinical-stage small interfering RNA (siRNA) therapeutics company Argo Biopharmaceutical Co., Ltd. (Argo Biopharma) announced that it will present Phase I data for BW-20805 at the American College of Allergy, Asthma & Immunology (ACAAI) 2025 Annual Scientific Meeting, which will be held in Orlando, Florida, USA, from November 6–10.
Prekallikrein (PKK), a well-established target for the treatment of hereditary angioedema (HAE), is targeted and inhibited by the experimental siRNA therapy BW-20805, which may prevent HAE attacks and have a major, long-term impact.
The poster presentation, titled “Hereditary Angioedema Prophylaxis With Prekallikrein siRNA—Phase 1 Safety Outcomes And Prekallikrein Levels,” will be presented throughout the ACAAI meeting. These data underscore the well-tolerated nature of BW-20805, its favorable safety profile, and its achievement of rapid, profound, and sustained reductions in plasma PKK levels.
Key findings:
- BW-20805 was generally well tolerated across all dose levels (50–600 mg), with no dose-dependent increase in treatment-emergent adverse events (TEAEs).
- No deaths, serious adverse events (SAEs) related to the study drug, or discontinuations due to TEAEs were reported.
- Treatment with BW-20805 led to rapid, profound, and durable reductions in plasma PKK levels, achieving mean maximum reductions of approximately 75% (50 mg), 87% (150 mg), 94% (300 mg), and 95% (600 mg).
- PKK suppression was sustained for up to 24 weeks, supporting the potential for 6-month dosing intervals.
- Other pharmacodynamic biomarkers, including plasma proenzyme activation and cleaved high-molecular-weight kininogen (cHMWK), also showed significant reductions, reinforcing the drug’s biological activity.
“We are pleased with the results shared at ACAAI, showing that BW-20805 was well tolerated across all dose levels, with rapid, profound, and durable reductions in plasma PKK levels achieved,” stated Dr. Dongxu Shu, co-founder and Chief Executive Officer of Argo Biopharma. “We look forward to further advancing BW-20805 as a potential long-acting and effective therapy for people living with HAE.”
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