AusperBio has completed patient enrolment for the Phase III AUSHINE clinical trial evaluating AHB-137 for chronic hepatitis B (CHB).
The multicentre, randomised, double-blind study is assessing the safety and efficacy of AHB-137 injection in participants with HBeAg-negative CHB who are receiving nucleos(t)ide analogue therapy.
CHB continues to present a significant public health challenge globally. According to the World Health Organization (WHO) Global Hepatitis Report 2024, there are nearly 254 million individuals living with hepatitis B virus (HBV) globally, with 1.2 million new infections each year.
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AHB-137 is an unconjugated antisense oligonucleotide (ASO) developed using AusperBio’s Med-Oligo ASO platform, intended to achieve a functional cure of CHB.
The investigational therapy’s mechanism integrates immune reactivation, targeted HBsAg suppression at the transcriptional level, and inhibition of viral DNA replication.
It has completed a global Phase I trial and is currently being assessed in multiple Phase II studies alongside the ongoing Phase III trial in China.
The global development strategy for AHB-137 aims to deliver a treatment that could potentially offer a functional cure for HBV infection.
AusperBio co-founder and CEO Dr Guofeng Cheng said: “The successful enrolment of over 570 patients ahead of schedule marks a critical milestone in our mission to advance a functional cure for CHB.
“Full enrolment was achieved within five months of China CDE approval, reflecting the strong engagement and dedication of the investigators, patients, clinical teams who partnered with us in this programme.
“We are deeply grateful and remain firmly committed to advancing AHB-137 through a rigorous registrational pathway, guided by strong science and a clear focus on delivering a paradigm-shifting treatment for people living with CHB.”
In September 2025, AusperBio completed participant enrolment in two Phase II studies evaluating AHB-137 for the functional cure of CHB.
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