AusperBio Completes Phase III Enrollment for AHB-137 Hepatitis B Therapy Following 30% Functional Cure Rate
核心洞察
AusperBio completed patient enrollment in its Phase III AUSHINE trial of AHB-137, enrolling over 570 HBeAg-negative chronic hepatitis B (搜索) patients within five months of regulatory approval.
The antisense oligonucleotide therapy demonstrated a 30% functional cure rate in Phase IIa studies for patients with baseline HBsAg levels of 100-1,000 IU/mL at 72-week follow-up.
AHB-137 employs a triple-mechanism approach targeting HBsAg suppression, viral DNA replication inhibition, and immune reactivation to address the unmet need for functional cure in chronic hepatitis B (搜索).
AusperBio Therapeutics (搜索) has completed patient enrollment in its pivotal Phase III AUSHINE clinical trial evaluating AHB-137, a novel antisense oligonucleotide therapy for chronic hepatitis B (搜索) (CHB), marking a significant milestone in the pursuit of functional cure for this global health challenge. The company enrolled over 570 patients ahead of schedule, achieving full enrollment within five months of China CDE approval.
Phase III Trial Design and Patient Population
The AUSHINE study (CTR20252792/NCT07246889) is a randomized, double-blind, multicenter Phase III trial evaluating the efficacy and safety of AHB-137 injection in participants with HBeAg-negative CHB treated with nucleos(t)ide analogue (搜索) (NA) therapy. The rapid enrollment pace exceeded initial expectations and positions the program for accelerated progression toward its primary endpoint readout.
"For the vast majority of HBeAg-negative CHB patients receiving long-term nucleos(t)ide analogue (搜索) therapy, treatment today is only suppressive rather than curative," said Professor Jian Sun, principal investigator and President of Nanfang Hospital, Southern Medical University (搜索). "Functional cure remains an urgent unmet goal for this large patient population, most of whom face lifelong therapy with ongoing risk of disease progression."
Clinical Efficacy Data Supporting Phase III Advancement
The Phase III enrollment completion follows encouraging efficacy data from AusperBio's Phase IIa study (AB-10-8002), which demonstrated that finite-duration 24-week AHB-137 monotherapy achieved a 30% functional cure rate at Week 72 end-of-follow-up in patients with baseline HBsAg levels of 100-1,000 IU/mL. These results were presented at the HEP-DART 2025 conference in December.
"The encouraging clinical efficacy observed to date, including a functional cure rate of approximately 30% recently presented at the HEP-DART 2025 conference, reinforces our confidence in the triple-mechanistic activities of AHB-137 and its potential to deliver functional cure for CHB patients," said Dr. Chris Yang, Co-founder and CSO of AusperBio.
Triple-Mechanism Therapeutic Approach
AHB-137 is an unconjugated antisense oligonucleotide designed using AusperBio's proprietary Med-Oligo™ ASO technology platform. The therapy's mechanism integrates three complementary actions: targeted suppression of HBsAg at the transcriptional level, inhibition of viral DNA replication, and immune reactivation. This novel approach aims to address the limitations of current suppressive therapies.
Addressing Global Health Burden
Chronic hepatitis B (搜索) remains a major global public health challenge. According to the World Health Organization Global Hepatitis Report 2024, approximately 254 million people worldwide are living with hepatitis B virus (搜索) (HBV), with 1.2 million people newly infected annually. In China alone, an estimated 75 million are chronically infected.
"The successful enrollment of over 570 patients ahead of schedule marks a critical milestone in our mission to advance a functional cure for chronic hepatitis B (搜索)," said Dr. Guofeng Cheng, Co-founder and CEO of AusperBio. "Full enrollment 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 program."
Development Pipeline and Global Strategy
AHB-137 has completed a global Phase I study and is currently being evaluated in multiple Phase II studies alongside the Phase III trial in China. The therapy has demonstrated promising preclinical and clinical results, with key findings presented at major international hepatology congresses including EASL (2023-2025), AASLD (2024-2025), and APASL (2025).
The company's coordinated global development strategy supports AHB-137's advancement toward delivering a potential functional cure for HBV infection, representing a paradigm shift from current suppressive treatments to curative approaches for chronic hepatitis B (搜索) patients.