AusperBio Gets CDE Approval for Phase III Trial of AHB-137 in Chronic Hepatitis B

AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd., collectively known as AusperBio, have announced a major milestone in their pursuit of a functional cure for chronic hepatitis B (CHB). The China Center for Drug Evaluation (CDE) has granted approval for a Phase III clinical trial of their lead candidate, AHB-137. This trial aims to evaluate the efficacy and safety of a 24-week treatment regimen with AHB-137 (300 mg) in HBeAg-negative CHB patients who are already on stable nucleos(t)ide analogue therapy.

Chronic hepatitis B is a liver disease that affects an estimated 290 million people worldwide, with about 75 million cases in China alone. The disease can lead to severe complications such as cirrhosis and hepatocellular carcinoma. Current treatments primarily suppress viral replication, but achieving a functional cure remains uncommon.

AHB-137 is a novel antisense oligonucleotide designed as a potential functional cure for CHB. In July 2024, it received Breakthrough Therapy Designation from the China CDE, highlighting its potential to significantly improve treatment outcomes compared to existing therapies. In March 2025, important findings from the Phase IIa study were presented at the Asia-Pacific Association for the Study of the Liver (APASL) conference. Subsequently, in May 2025, end-of-treatment results from the Phase IIb trial were shared at the European Association for the Study of the Liver (EASL) Congress in Amsterdam.

Dr. Guofeng Cheng, Co-founder and CEO of AusperBio, expressed excitement over the CDE's approval for launching Phase III development of AHB-137. This approval, following the Breakthrough Designation received the previous year, underscores the encouraging efficacy and safety profile of their clinical data. Dr. Cheng emphasized that this milestone strengthens their confidence in AHB-137 as a potential key therapy for CHB and marks a significant step forward in the development of functional cure therapies for hepatitis B.

Dr. Chris Yang, Co-founder and Chief Scientific Officer, extended gratitude to all involved in reaching this significant achievement, including investigators, clinical teams, trial participants, and colleagues at AusperBio. He stated the company’s intention to commence this crucial trial soon, aiming to provide a transformative treatment option to CHB patients.

The approval for this Phase III trial represents a major advancement in AusperBio's mission to develop science-based, patient-centered treatments for chronic hepatitis B on a global scale.

AHB-137 is an unconjugated antisense oligonucleotide (ASO) designed using AusperBio's proprietary Med-Oligo™ ASO technology platform. It has been developed as an investigational medicine targeting a functional cure for CHB. The clinical development of AHB-137 has generated promising data, with notable results presented at leading global conferences, including the EASL and APASL. This innovative ASO, employing a dual-mechanism, has completed its global Phase 1 trial and is currently progressing through multiple Phase 2 studies in China. With a clear global development strategy, AHB-137 is rapidly moving towards providing a potential cure for hepatitis B virus (HBV).

AusperBio is a clinical-stage biopharmaceutical company operating in the USA and China. It is committed to advancing oligonucleotide and targeted delivery technologies for transformative therapies, initially focusing on achieving a functional cure for chronic hepatitis B infection. The company's proprietary Med-Oligo™ ASO platform significantly enhances current ASO therapeutics by incorporating novel insights into ASO design. Combined with targeted delivery conjugation technologies, the Med-Oligo™ Platform enables ASO therapeutics to address a wide range of diseases, including viral infections, metabolic conditions, genetic disorders, and immune diseases.