AusperBio Advances AHB-137 into Phase III Clinical Trials to Combat Chronic Hepatitis B in China

AusperBio's Leap Forward in Hepatitis B Treatment

AusperBio Therapeutics, a clinical-stage biotechnology company, has taken a significant step in the fight against chronic hepatitis B (CHB) with the recent approval for its lead candidate AHB-137 to advance into Phase III clinical trials. The China Center for Drug Evaluation (CDE) granted this clearance, allowing AusperBio to explore the efficacy and safety of AHB-137 in a randomized, double-blind, multicenter study across China.

Chronic hepatitis B is a pressing health issue, affecting around 290 million people worldwide, with approximately 75 million of those patients residing in China alone. The disease can lead to severe health complications, including liver cirrhosis and hepatocellular carcinoma, making the need for effective treatments urgent. Although there are therapies that can suppress the virus, a true functional cure remains elusive for many patients. AusperBio's AHB-137, which is underpinned by innovative antisense oligonucleotide technology, is designed to tackle this challenge directly.

Understanding AHB-137

AHB-137 is a novel unconjugated antisense oligonucleotide (ASO) that has garnered significant attention due to its dual-action mechanism aimed at achieving a functional cure for CHB. The development journey of AHB-137 has already seen important milestones, including receiving the Breakthrough Therapy Designation from the CDE in July 2024. This designation is awarded to treatments showing great promise in addressing unmet medical needs, and it reflects AusperBio's confidence in AHB-137’s potential effectiveness compared to existing therapies.

In March 2025, key Phase IIa trial data, showcasing AHB-137's safety and efficacy, was prominently shared at the Asia-Pacific Association for the Study of the Liver (APASL) conference. Furthermore, in May of the same year, the end-of-treatment results from the Phase IIb trial were presented at the notable European Association for the Study of the Liver (EASL) Congress in Amsterdam, further solidifying its standing in the scientific community.

The Importance of Phase III Trials

The Phase III clinical trial will focus on HBeAg-negative CHB patients currently receiving stable nucleos(t)ide analogue treatment and aims to validate the findings from earlier phases. AusperBio’s CEO, Dr. Guofeng Cheng, expressed great enthusiasm about this advancement, emphasizing it as a critical milestone in their pursuit of developing a cornerstone therapy for CHB. This upcoming trial is expected to be crucial in establishing a new standard for treating CHB, aiming to change the lives of millions affected by this chronic disease.

In his statement, Dr. Cheng noted, "This approval, following the 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."

Additionally, Dr. Chris Yang, Chief Scientific Officer of AusperBio, acknowledged the collaborative efforts of the clinical teams, researchers, and trial participants, stating, "We intend to begin this crucial trial soon, with the goal of providing a transformative treatment option to CHB patients."

Looking Ahead

The initiation of the Phase III trial is not just an achievement for AusperBio but represents a significant progression in the global battle against chronic hepatitis B. With a well-defined strategy and promising data behind it, AHB-137’s development could redefine how CHB is treated worldwide. AusperBio’s unwavering commitment to advancing oligonucleotide therapies sets the stage for potential breakthroughs in not only hepatitis B treatments but also in addressing a myriad of other diseases requiring innovative therapeutic solutions.

With the potential to vastly improve treatment outcomes for millions, the journey of AHB-137 is one to closely follow in the coming years as it strives toward the goal of becoming a functional cure for chronic hepatitis B—illuminating hope for patients and families affected by this relentless disease.