AusperBio Completes Enrollment in Two Phase II Clinical Trials of AHB-137 for Chronic Hepatitis B

SAN FRANCISCO, Sept. 18, 2025 /PRNewswire/ -- AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. (collectively AusperBio), a clinical-stage biotechnology company advancing targeted oligonucleotide therapies for chronic hepatitis B (CHB) functional cure, today announced the completion of patient enrollment in two Phase II clinical trials evaluating its lead candidate, AHB-137, in patients with chronic hepatitis B (CHB), marking an important milestone in the clinical development program.

The Phase II study AB-10-8007 (NCT07069569) is a randomized, open-label, multicenter study to evaluate the efficacy and safety of AHB-137 Injection in combination with either a hepatitis B vaccine or pegylated interferon α-2b (Peg-IFN) in participants with HBeAg-negative CHB receiving nucleos(t)ide analogue (NA) therapy.

The Phase II study AB-10-8008 (NCT06829329) is a randomized, multicenter study to evaluate the efficacy and safety of AHB-137 Injection in treatment-naïve participants with CHB.

"Combination therapies have historically been a key to treat or cure chronic viral infections, including HIV and HCV." said Dr. Guofeng Cheng, Co-founder and CEO of AusperBio. "The AB-10-8007 study aims to combine AHB-137 with approved HBV treatments to further increase functional cure rates, while the AB-10-8008 study explores the potential to expand AHB-137 treatment to a broader patient population. Together, these studies could further establish AHB-137 as the potential backbone therapy for HBV functional cure. We look forward to sharing interim results at international conferences throughout 2026."

"We are deeply grateful to the patients, investigators, site teams, and our AusperBio colleagues for their dedication and contributions to reaching this important milestone," said Dr. Chris Yang, Co-founder and CSO of AusperBio. "The completion of enrollment in these Phase II trials positions us well as we move into the pivotal Phase III study of AHB-137, which was recently approved in China. We are excited and committed to advancing new treatment options with the goal of bringing a functional cure to a broader population of patients living with HBV."

About AHB-137

AHB-137, a novel unconjugated antisense oligonucleotide (ASO) designed using AusperBio's proprietary Med-Oligo™ ASO technology platform and an investigational medicine, is being developed to achieve a functional cure for chronic hepatitis B. Its clinical development has generated promising data, with key preclinical and clinical results presented at global leading conferences including EASL (2023, 2024, 2025), AASLD (2024), and APASL (2025). This novel dual-mechanism ASO has completed its global Phase 1 trial and is currently advancing through multiple Phase 2 trials and a phase 3 trial in China. Supported by a clear global development strategy, AHB-137 is progressing rapidly toward delivering a potential cure for HBV.

About AusperBio.

AusperBio is a clinical-stage biopharmaceutical company with operations in the USA and China, dedicated to advancing oligonucleotide and targeted delivery technologies for transformative therapies, with an initial focus on achieving functional cure for chronic hepatitis B infection. The company has developed a proprietary Med-Oligo™ ASO platform which has been shown to substantially enhance the current ASO therapeutics, through novel insights into ASO design. Combining with efficient targeted delivery conjugation technologies, the modular Med-Oligo™ Platform empowers ASO therapeutics to treat a broad range of diseases, including viral infections, metabolic conditions, genetic disorders, and immune diseases.

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SOURCE AusperBio Therapeutics Inc.