BOWAVE Pharmaceuticals Announces Phase I Clinical Data for siRNA Therapeutic BW-20805 Targeting Hereditary Angioedema at ACAAI 2025

Nov 10, 2025 08:01 CST Updated 08:01

Argo

RNAi Drug Developer

Argo Biopharma's siRNA New Drug BW-20805 Presents Phase I Clinical Research Data at the 2025 ACAAI Conference for the Treatment of Hereditary Angioedema (HAE)

Shanghai, China and Boston, USA — Argo Biopharma (referred to as “Argo”), a clinical-stage biotechnology company, recently presented the Phase I clinical data of BW-20805 at the 2025 Annual Meeting of the American College of Allergy, Asthma & Immunology (ACAAI). The conference was held from November 6 to 10 in Orlando, Florida, USA.

BW-20805 is an siRNA therapy targeting prekallikrein (PKK). By inhibiting the expression of PKK, it has the potential to prevent attacks of hereditary angioedema (HAE) and exhibits significant long-acting therapeutic potential. PKK and its active form, kallikrein, are well-validated therapeutic targets in the field of HAE treatment.

Poster (Poster Number: R094) titled "Preventive Effects of Prekallikrein siRNA on Hereditary Angioedema - Phase 1 Safety Outcomes and Prekallikrein Levels" will be presented during the ACAAI meeting. The data show that BW-20805 demonstrated good tolerability and safety in clinical trials, with rapid, deep, and sustained reductions in plasma PKK levels.

Key research findings released at the ACAAI conference include:

BW-20805 was generally well-tolerated at all tested doses (50-600 mg), with no dose-dependent increase in treatment-emergent adverse events (TEAEs).

No deaths, serious adverse events (SAE) related to the study drug, or treatment discontinuations due to TEAE were reported in the trial.
After treatment with BW-20805, plasma PKK levels achieved rapid, significant, and sustained reductions, with average decreases of 75% (50 mg), 87% (150 mg), 94% (300 mg), and 95% (600 mg), respectively.
PKK inhibition lasts up to 24 weeks, with the potential for a six-month dosing interval.
Other pharmacodynamic biomarkers, including plasma pre-enzyme activation and cleaved high molecular weight kininogen (cHMWK), were also significantly reduced, further confirming the bioactivity of the drug.

Dr. Dongxu Shu, co-founder and CEO of Argo Biopharma, stated: "We are confident in ourACAAIWe are encouraged by the therapy data released at the meeting. The research results show,BW-20805Demonstrated good tolerability at all dose levels and rapidly, significantly, and durably reduced plasmaPKK Level. We look forward to continuously advancing R&D, striving to HAE "Patients are provided with a potentially long-acting treatment option."

About Hereditary Angioedema (HAE)

Hereditary Angioedema (HAE) Is a rare genetic disorder that causes unpredictable swelling in different parts of the body. Severe cases can present with laryngeal edema, with a mortality rate as high as approximately40% ¹. It is estimated that globally every10 Approximately in 10,000 people1.5 People affected by this disease²。Existing therapies require frequent dosing, thus there is a significant unmet need among patients for long-acting preventive treatment options. BW-20805 Targeting Human Liver PKK mRNA To suppress PKK Gene expression, thereby achieving efficient and long-lastingHAESeizure Prevention.

References:

1. Pedro Giavina-Bianchi，et at.CLINICS(2011);66(9):1627-1636

2. Aygören-Pürsün, E., et al. (2018). Orphanet J Rare Dis 13(1): 73.

About Argo Biopharma

Argo Biopharma is a clinical-stage biotechnology company dedicated to developing a new generation of RNAi therapies, providing better treatment options for patients worldwide. The company leverages its liver-targeting and extrahepatic delivery technology platforms to build a diversified RNAi drug R&D pipeline covering cardiometabolic diseases, specialty diseases, viral infections, central nervous system disorders, and rare diseases. Currently, Argo Biopharma has six RNAi candidate drugs in clinical trials.