AusperBio Receives China CDE Clearance for Phase III Trial of Hepatitis B Antisense Therapy AHB-137
核心洞察
AusperBio (搜索) received China Center for Drug Evaluation (搜索) clearance to initiate a Phase III clinical trial for AHB-137, a novel antisense oligonucleotide therapy targeting chronic hepatitis B functional cure.
The Phase III trial will evaluate 24-week treatment with AHB-137 (300 mg) in HBeAg-negative chronic hepatitis B patients receiving stable nucleos(t)ide analogue therapy.
AHB-137 previously received Breakthrough Therapy Designation from China CDE in July 2024, recognizing its potential to significantly improve treatment outcomes compared to existing therapies.
AusperBio Therapeutics (搜索) announced that the China Center for Drug Evaluation (搜索) (CDE) has approved the initiation of a Phase III clinical trial for AHB-137, the company's lead antisense oligonucleotide therapy designed to achieve a functional cure for chronic hepatitis B (CHB). The approval represents a significant regulatory milestone for the clinical-stage biotechnology company's efforts to address a major global health challenge.
Phase III Trial Design and Patient Population
The Phase III study will be conducted as a randomized, double-blind, multicenter trial in China, evaluating the efficacy and safety of 24-week treatment with AHB-137 at a 300 mg dose. The trial will focus on HBeAg-negative CHB patients who are receiving stable nucleos(t)ide analogue therapy, representing a specific patient population where current treatments often fall short of achieving functional cure.
Addressing a Global Health Challenge
Chronic hepatitis B infection affects an estimated 290 million people globally, including approximately 75 million in China. The liver disease can cause serious chronic complications such as cirrhosis and hepatocellular carcinoma. Despite the availability of treatments that can suppress viral replication, a functional cure remains rare for most patients, highlighting the significant unmet medical need that AHB-137 aims to address.
Clinical Development Progress and Recognition
AHB-137 has demonstrated a promising development trajectory, receiving Breakthrough Therapy Designation from the China CDE in July 2024. This designation recognizes the therapy's potential to significantly improve treatment outcomes for CHB patients compared to existing treatments. The company has presented key clinical data at major international conferences, with Phase IIa study results featured in a late-breaker oral presentation at the Asia-Pacific Association for the Study of the Liver (APASL) conference in March 2025, and Phase IIb end-of-treatment results presented at the European Association for the Study of the Liver (EASL) Congress in Amsterdam in May 2025.
Novel Antisense Technology Platform
AHB-137 is an unconjugated antisense oligonucleotide designed using AusperBio (搜索)'s proprietary Med-Oligo™ ASO technology platform. The novel dual-mechanism ASO has completed its global Phase 1 trial and is currently advancing through multiple Phase 2 studies in China. The company's Med-Oligo™ platform has been developed to substantially enhance current ASO therapeutics through novel insights into ASO design.
Leadership Perspective
"We are thrilled to receive clearance from the China CDE to launch Phase III development of AHB-137," said Dr. Guofeng Cheng, Co-founder and CEO of AusperBio (搜索). "This approval, following Breakthrough Designation granted last year, reflects the promising efficacy and safety profile of our clinical data generated to date and reinforces our confidence in AHB-137 as a potential cornerstone therapy for chronic hepatitis B."
Dr. Chris Yang, Co-founder and CSO, emphasized the collaborative effort behind this achievement: "We would like to extend our sincere gratitude to the investigators, clinical teams, trial participants, and our dedicated AusperBio (搜索) colleagues who have helped us reach this significant achievement. We intend to begin this crucial trial soon, with the goal of providing a transformative treatment option to CHB patients."
Strategic Development Approach
The Phase III trial approval marks significant progress toward AusperBio (搜索)'s goal of developing science-based, patient-focused treatments aimed at achieving a functional cure for chronic hepatitis B on a global scale. The company operates with facilities in both the USA and China, positioning it to advance oligonucleotide and targeted delivery technologies for transformative therapies across multiple markets.