AusperBio Granted Approval to Begin Phase III Trial of AHB-137 for Chronic Hepatitis B
Tuesday, July 22, 2025
AusperBio has received clearance from the China Centre for Drug Evaluation (CDE) to initiate a Phase III clinical trial of AHB-137, their lead investigational candidate for the treatment of chronic hepatitis B (CHB).
Chronic hepatitis B is a widespread liver disease that affects nearly 290 million people worldwide, including around 75 million in China. The condition can lead to serious complications such as liver cirrhosis and hepatocellular carcinoma. While current treatments can suppress the virus, a functional cure remains uncommon.
AHB-137 is an antisense oligonucleotide developed using AusperBio’s proprietary Med-Oligo™ ASO platform. It is designed to offer a potential functional cure for CHB. In July 2024, AHB-137 was granted Breakthrough Therapy Designation by the China CDE, recognising its potential to provide improved outcomes over existing therapies. Results from earlier Phase II studies have been presented at major international conferences, including the APASL in March 2025 and the EASL Congress in May 2025.
The upcoming trial will be a randomised, double-blind, multicentre study conducted in China. It aims to assess the safety and effectiveness of AHB-137 (300 mg) over a 24-week period in HBeAg-negative CHB patients who are already on stable nucleos(t)ide analogue therapy.
The approval to begin Phase III trials follows promising clinical data and marks an important milestone in AusperBio’s efforts to develop targeted, science-based treatments for chronic hepatitis B. AHB-137 has already completed a global Phase I trial and continues to be evaluated in multiple Phase II studies within China.
AusperBio remains committed to advancing therapies that address critical needs in hepatitis B care and aims to contribute to global efforts to achieve a functional cure.
Source: ausperbio.com
