#USA #Istanbul #Argo Biopharma #BW-20805 #HAE Treatment

Argo Biopharma's Promising Phase II Results for BW-20805

Argo Biopharmaceutical Co., Ltd. (Argo Biopharma), a company dedicated to developing innovative small interfering RNA (siRNA) therapies, is preparing to present updated results from its Phase II clinical trial of BW-20805, targeting Hereditary Angioedema (HAE). This significant presentation will take place at the upcoming European Association of Allergy and Clinical Immunology (EAACI) Congress scheduled from June 12-15, 2026, in Istanbul, Türkiye. The announcement marks an important milestone in the company’s mission to combat HAE, a severe genetic condition that causes unpredictable swelling and can be life-threatening.

Promising Therapeutic Approach

BW-20805 represents a new and investigational siRNA therapy. Its mechanism of action targets and inhibits prekallikrein (PKK), a protein involved in the pathway that leads to the swelling associated with HAE attacks. Previous treatments for HAE have necessitated frequent dosing, which has underscored the need for a long-acting and preventive therapeutic option, which BW-20805 aims to fulfill.

Dr. Dongxu Shu, co-founder and CEO of Argo Biopharma, expressed enthusiasm about the upcoming presentation. He stated, "We are pleased that the updated analysis from the ongoing Phase II data for BW-20805 has been selected for presentation at EAACI 2026. Following the presentation at AAAAI 2025, this reflects the continued strength and progress of the program. We look forward to sharing the latest findings and advancing our efforts to develop a potentially meaningful treatment option for patients."

The study results selected for this late-breaking abstract presentation highlight the remarkable efficacy of BW-20805 in reducing HAE attacks.

Key Findings from the Study

The Phase II study, presented under the title "Long-Acting Prophylactic Injection BW-20805 Remarkable and Sustained HAE Attack Reduction — Updated Analysis from an Ongoing Phase 2 Study" (POSTER ID D1.363), showcases a significant decrease in HAE attacks across various dosing regimens. Key highlights include:

• - Dramatic Attack Rate Reduction: The time-normalized HAE attack rate saw a stunning reduction of 99% for patients receiving 600 mg dosed every 24 weeks (Q24W), with a remarkable 83% (5 out of 6 participants) remaining attack-free. Similarly, patients receiving 300 mg Q24W and 300 mg every 12 weeks (Q12W) experienced reductions of 93% and 95%, respectively, with 60% attack-free rates in both groups.
• - Sustained PKK Suppression: Analysis revealed that plasma PKK levels rapidly declined, achieving over 94% reductions in pooled participant groups receiving the 300 mg doses, and 96% for the 600 mg Q24W group by day 85. Among patients who completed the study for 169 days, mean PKK reductions remained robust, exceeding 90% across all treatment groups.
• - Safety Profile: The safety profile for BW-20805 appeared favorable, with the therapy well-tolerated among 18 participants across three treatment groups. Notably, there were no reports of severe adverse events (SAEs) related to the study drug, and no cases of treatment-emergent adverse events (TEAEs) leading to discontinuation or death, apart from mild, transient injection site reactions.

Understanding HAE

Hereditary Angioedema (HAE) is a rare genetic disorder characterized by unpredictable and sudden swelling in various body parts, including potentially life-threatening areas such as the throat. It affects approximately 1.5 individuals per 100,000 globally, and the condition is complicated by a high mortality rate - up to 40% in severe cases. The management of HAE is often complicated due to the need for frequent treatments, creating an urgent demand for long-acting preventive therapies like BW-20805.

Argo Biopharma's Vision

As a clinical-stage biotechnology firm, Argo Biopharma is at the forefront of developing next-generation RNAi therapeutics. The company is dedicated to providing innovative treatment options for a range of conditions, including cardiovascular ailments and rare diseases. Currently, they have seven RNAi candidates in clinical development, indicating a strong commitment to addressing unmet medical needs.

For more detailed information on the progress of BW-20805 and other projects, you can visit Argo Biopharma's official website. The presentation at the EAACI 2026 Congress not only signals a crucial step for the company but also a beacon of hope for patients affected by HAE worldwide.