Argo Biopharma to Present Phase I Data for siRNA Therapy BW-20805 at ACAAI 2025

Argo Biopharmaceutical Co., Ltd. (Argo Biopharma), a clinical-stage biotechnology company focused on small interfering RNA (siRNA) therapeutics, announced that it will present Phase I clinical data for its investigational therapy BW-20805 at the upcoming American College of Allergy, Asthma & Immunology (ACAAI) 2025 Annual Scientific Meeting, scheduled for November 6–10, 2025, in Orlando, Florida, USA.

About BW-20805

BW-20805 is an investigational siRNA therapy that targets and inhibits prekallikrein (PKK) — a well-validated therapeutic target for hereditary angioedema (HAE). The candidate aims to provide preventive treatment for HAE attacks with a long-term therapeutic effect.

The presentation, titled “Hereditary Angioedema Prophylaxis With Prekallikrein siRNA – Phase 1 Safety Outcomes and Prekallikrein Levels” (Poster ID: R094), will be available throughout the ACAAI meeting.

Key Phase I Findings

• Safety: BW-20805 was well tolerated across all dose levels (50–600 mg), with no dose-dependent increase in treatment-emergent adverse events (TEAEs).
• Adverse Events: No deaths, serious adverse events (SAEs) related to the study drug, or discontinuations due to TEAEs were reported.
• Pharmacodynamics: The therapy led to rapid, profound, and sustained reductions in plasma PKK levels — achieving mean maximum reductions of approximately 75% (50 mg), 87% (150 mg), 94% (300 mg), and 95% (600 mg).
• Duration of Effect: PKK suppression lasted up to 24 weeks, suggesting potential for six-month dosing intervals.
• Biomarker Response: Additional biomarkers, such as plasma proenzyme activation and cleaved high-molecular-weight kininogen (cHMWK), also showed marked reductions, supporting 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,” said 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.”

About Hereditary Angioedema (HAE)

Hereditary angioedema is a rare genetic disorder characterized by sudden and unpredictable swelling in various parts of the body. Severe cases may involve the throat, posing life-threatening risks with a mortality rate of up to 40%. The condition affects approximately 1.5 individuals per 100,000 people worldwide.

Current treatment options often require frequent dosing, underscoring the need for long-acting preventive therapies. BW-20805 acts by targeting hepatic PKK mRNA to inhibit gene expression, potentially offering durable protection against HAE attacks.

About Argo Biopharma

Argo Biopharma is a clinical-stage RNAi therapeutics company dedicated to advancing next-generation RNA interference therapies across multiple therapeutic areas, including cardiovascular, viral, metabolic, and rare diseases. The company currently has six RNAi candidates in clinical development and aims to deliver innovative, durable, and targeted treatment options for patients worldwide.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!