BW-20805 / Argo Biopharma - LARVOL DELTA

Status of Current Clinical Trials on Therapy for Hereditary Angioedema (IMMUNOLOGY 2026) - "The sole drug in phase 4 is CSL312 (Garadacimab), a fully human IgG4 monoclonal antibody targeting activated factor XIIa. Drugs in phase 3 include: NTLA-2002, a single-dose intravenous gene therapy targeting inactivation of the KLKB1 gene; Navenibart, an IgG1 monoclonal antibody inhibiting activated kallikrein; OCTA-C1-INH, a virus-inactivated, nanofiltrated, highly purified concentrate of C1-INH derived from pooled human plasma; ADX-324, an siRNA therapy to reduce hepatic production of prekallikrein (PKK); Donidalorsen, an antisense oligonucleotide targeted against hepatic PKK mRNA; Sebetralstat and berotralstat, both plasma kallikrein inhibitors that reduce production of bradykinin; and deucrictibant, a competitive bradykinin B2 receptor antagonist. Advances in gene therapy, biologics, RNA interference therapeutics, and improved replacement strategies hold promise for transforming both rescue and prophylactic management for HAE. Ongoing evaluation of safety,..."

Clinical • Cardiovascular • Complement-mediated Rare Disorders • Gene Therapies • Hereditary Angioedema • AVEN

HV: A Phase 1 Clinical Study of BW-20805-2-1001 in Healthy Participants (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Shanghai Argo Biopharmaceutical Co., Ltd.

New P1 trial

Argo Biopharma…announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to its novel siRNA therapy BW-20805, for the treatment of hereditary angioedema (HAE) (PRNewswire) - "Argo Biopharma is currently conducting a global Phase II study in adult HAE patients. The Company anticipates primary completion of the Phase II study in the second half of 2026, followed by plans for a global Phase III study."

Fast track • Trial status • Hereditary Angioedema

HAE: A Phase 2 in Adult Subjects With Hereditary Angioedema (clinicaltrials.gov) - P2 | N=25 | Active, not recruiting | Sponsor: Shanghai Argo Biopharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Complement-mediated Rare Disorders • Hereditary Angioedema

BW-20805-2001: A study to investigate the effect and safety of BW-20805 in adult participants with hereditary angioedema (clinicaltrialsregister.eu) - P1/2 | N=10 | Active, not recruiting | Sponsor: Shanghai Argo Biopharmaceutical Co. Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Complement-mediated Rare Disorders • Hereditary Angioedema

Significant HAE Attack Reduction with BW-20805, a Long-Acting Prophylactic Injection- An Ongoing Phase 2 Study in Adult with Hereditary Angioedema (AAAAI 2026) - "Sustained PKK suppression supports further evaluation of a Q24W dosing regimen. The Phase 2 study remains ongoing, with additional data to follow."

Clinical • Late-breaking abstract • P2 data • Cardiovascular • Complement-mediated Rare Disorders • Hereditary Angioedema

Hereditary Angioedema Prophylaxis With Prekallikrein siRNA-Phase 1 Safety Outcomes And Prekallikrein Levels (ACAAI 2025) - "Conclusion The Phase 1 study results provide the evidence that BW-20805 is safe and significantly reduces PKK levels in a dose-dependent manner for 24 weeks. This should translate into effective prevention of HAE attacks with convenient dosing intervals potentially extending up to 6 months."

Clinical • P1 data • Cardiovascular • Complement-mediated Rare Disorders • Hereditary Angioedema

HAE: A Phase 2 in Adult Subjects With Hereditary Angioedema (clinicaltrials.gov) - P2 | N=24 | Recruiting | Sponsor: Shanghai Argo Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Complement-mediated Rare Disorders • Hereditary Angioedema

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BW-20805 in Healthy Subjects (ANZCTR) - P1 | N=32 | Completed | Sponsor: Argo Biopharma Australia Pty Ltd | Recruiting ➔ Completed

Trial completion • Cardiovascular • Complement-mediated Rare Disorders • Hereditary Angioedema

HAE: A Phase 2 in Adult Subjects With Hereditary Angioedema (clinicaltrials.gov) - P2 | N=24 | Not yet recruiting | Sponsor: Shanghai Argo Biopharmaceutical Co., Ltd.

New P2 trial • Cardiovascular • Complement-mediated Rare Disorders • Hereditary Angioedema

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BW-20805 in Healthy Subjects (ANZCTR) - P1 | N=32 | Recruiting | Sponsor: Argo Biopharma Australia Pty Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Trial initiation date • Cardiovascular • Complement-mediated Rare Disorders • Hereditary Angioedema • IFNG • IL6 • TNFA