Home BoWang Pharma to Present Phase I/IIa Clinical Data of siRNA Therapeutic BW-20507 for Chronic Hepatitis B at EASL 2025 Late-Breaker Session

BoWang Pharma to Present Phase I/IIa Clinical Data of siRNA Therapeutic BW-20507 for Chronic Hepatitis B at EASL 2025 Late-Breaker Session

May 09, 2025 08:04 CST Updated 08:04
Argo

RNAi Drug Developer

Argo Biopharma's siRNA New Drug BW-20507 for the Treatment of Chronic Hepatitis B: Phase I/IIa Clinical Study Data to Be Featured in the Late-Breaking Advances Session at the 2025 European Association for the Study of the Liver (EASL) Annual Meeting


Shanghai, China; Boston, USA — May 7, 2025——Argo Biopharma, a clinical-stage biotechnology company, today announced that it will present Phase I/IIa clinical research data for its innovative small interfering RNA (siRNA) therapy, BW-20507, for the treatment of chronic hepatitis B (CHB), at the European Association for the Study of the Liver (EASL) Annual Meeting to be held in Amsterdam, Netherlands, from May 7 to 10, 2025.


The poster "Safety, Tolerability, and Remarkable Hepatitis B Surface Antigen Reduction in Chronic Hepatitis B Patients Treated With BW-20507" (Poster Number: LBP-008) will be displayed in the Late-Breaker session of the conference. The poster summarizes key research data on the use of BW-20507 monotherapy in virologically suppressed and nucleos(t)ide (NUC) treatment-naïve chronic hepatitis B patients, with the study conducted in Hong Kong, China, and Thailand.


BW-20507 is an siRNA molecule targeting the S region of hepatitis B virus (HBV) messenger RNA, developed by Argo based on its proprietary RNAi platform and unique proprietary technology for the treatment of chronic hepatitis B.


Dr. Dongxu Shu, Co-founder, Chairman of the Board, and CEO of Argo Biopharma, stated: "The molecule developed by Argo's team of scientists and clinical development team has demonstrated remarkable efficacy in early clinical studies. This drug holds promise to address the unmet medical needs of patients with hepatitis B. It is the fourth molecule developed by Argo that has shown clinical differentiation in terms of efficacy, dosing, and safety. This achievement marks a significant milestone in the development of BW-20507 and brings hope for improved treatment options for patients with chronic hepatitis B."


Key Research Findings Released at the EASL Annual Meeting

  • BW-20507 administered subcutaneously once every four weeks for a total of three doses significantly reduced HBsAg levels in a dose-dependent manner, with maximum reductions of 2.9~3.2 log₁₀ IU/mL observed in the 200mg and 400mg dose groups.


  • In subjects with baseline HBsAg levels below 1,000 IU/mL, 56% (5/9 cases) achieved HBsAg clearance during the study period.


  • Strong HBV DNA suppression was also observed in treatment-naïve subjects not concurrently receiving NUC therapy.


  • BW-20507 Demonstrates Prominent Antiviral Efficacy and Good Safety and Tolerability, Laying the Foundation for Subsequent Clinical Development.


"These data represent a significant advancement in the research on functional cure for chronic hepatitis B," said Professor Man-Fung Yuen from Queen Mary Hospital, The University of Hong Kong, who was the principal investigator of the study and the presenting author at the 2025 EASL conference. "Particularly encouraging is that some patients have already shown HBsAg clearance after receiving only three doses of BW-20507, which is extremely rare in other siRNA monotherapies. These results bring new hope for a functional cure for patients with chronic hepatitis B."


Based on these positive results, Argo Biopharma plans to initiate Phase IIb clinical development of BW-20507 in 2025. The monotherapy Phase IIb study is expected to commence in the second quarter of 2025, while the combination therapy Phase IIb study is anticipated to start in the third quarter, aiming to further evaluate the potential of BW-20507 in achieving functional cure for chronic hepatitis B.

About Chronic Hepatitis B


Chronic HBV infection is one of the leading causes of liver disease globally, affecting approximately 296 million people and resulting in around 820,000 deaths annually due to severe complications such as cirrhosis, liver decompensation, and hepatocellular carcinoma (HCC). Currently, there remains a significant unmet medical need for treatments targeting functional cures for chronic hepatitis B.


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 disorders, specialty diseases, viral infections, central nervous system diseases, and rare diseases. Currently, Argo Biopharma has six RNAi candidate drugs in clinical studies.

In January 2024, Argo Biopharma reached a significant strategic cooperation with Novartis, receiving an upfront payment of $185 million, with the total value of the deal exceeding $4 billion.


For more information, please visit

 www.argobiopharma.com。