Drugs / BW-20805
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT07528053 | Apr → Jun 2026 overdue | — | Shanghai Argo Biopharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT06846398 | Feb 2025 → Jun 2026 overdue | hereditary angioedema | Shanghai Argo Biopharmaceutical Co., Ltd. | Active not recruiting | Met primary |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-09-04 | Shanghai Argo Biopharmaceutical Co., Ltd. | Results Argo Biopharma to Present Positive Phase II Updated Results of siRNA Therapeutic BW-20805 for HAE at Bradykinin Symposium 2026 argobiopharma.com ↗
The magnitude and durability of attack-rate reduction observed through Day 169, together with sustained PKK suppression and a well-tolerated safety profile, support continued advancement of this program as we work to address the need for effective therapies with less frequent dosing. |
| 2026-06-08 | Shanghai Argo Biopharmaceutical Co., Ltd. | Results Argo Biopharma to Present Positive Phase II Updated Results of siRNA Therapeutic BW-20805 for HAE at the EAACI 2026 Congress argobiopharma.com ↗
The sustained and robust PKK suppression supports further evaluation of a Q6M dosing regimen. |
| 2026-03-16 | Shanghai Argo Biopharmaceutical Co., Ltd. | Regulatory Argo Biopharma Receives FDA Fast Track Designation for BW-20805, an Investigational siRNA Therapy for the Treatment of HAE argobiopharma.com ↗
Argo Biopharmaceutical Co., Ltd. (Argo Biopharma), a clinical-stage small interfering RNA (siRNA) therapeutics company, today 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) . |
| 2026-02-26 | Shanghai Argo Biopharmaceutical Co., Ltd. | Results Argo Biopharma to Present Positive Phase II Interim Results of siRNA Therapeutic BW-20805 for HAE at the 2026 AAAAI Annual Meeting argobiopharma.com ↗
The open-label study results, selected as a late breaking abstract presentation, titled "Significant HAE Attack Reduction with BW-20805, a Long-Acting Prophylactic Injection-An Ongoing Phase 2 Study in Adults with Hereditary Angioedema" (POSTER ID: L42), show that BW-20805 provides remarkable plasma PKK reduction, along with meaningful time-normalized HAE attack rate reduction. |
| 2025-11-07 | Shanghai Argo Biopharmaceutical Co., Ltd. | Results Argo Biopharma to Present Positive Phase I Results of siRNA Therapeutic BW-20805 for HAE at ACAAI 2025 argobiopharma.com ↗
These data highlight that BW-20805 was well tolerated and demonstrated a favorable safety profile and achieved rapid, profound, and sustained reductions in plasma PKK levels. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-09-04 | Shanghai Argo Biopharmaceutical Co., Ltd. | Argo Biopharma to Present Positive Phase II Updated Results of siRNA Therapeutic BW-20805 for HAE at Bradykinin Symposium 2026 argobiopharma.com ↗ |
| 2026-06-08 | Shanghai Argo Biopharmaceutical Co., Ltd. | Argo Biopharma to Present Positive Phase II Updated Results of siRNA Therapeutic BW-20805 for HAE at the EAACI 2026 Congress argobiopharma.com ↗ |
| 2026-03-16 | Shanghai Argo Biopharmaceutical Co., Ltd. | Argo Biopharma Receives FDA Fast Track Designation for BW-20805, an Investigational siRNA Therapy for the Treatment of HAE argobiopharma.com ↗ |
| 2026-02-26 | Shanghai Argo Biopharmaceutical Co., Ltd. | Argo Biopharma to Present Positive Phase II Interim Results of siRNA Therapeutic BW-20805 for HAE at the 2026 AAAAI Annual Meeting argobiopharma.com ↗ |
| 2025-11-07 | Shanghai Argo Biopharmaceutical Co., Ltd. | Argo Biopharma to Present Positive Phase I Results of siRNA Therapeutic BW-20805 for HAE at ACAAI 2025 argobiopharma.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BW-20805 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07528053 ↗ |
| Route | Subcutaneous | “SC administrations of BW-20805” NCT06846398 ↗ |