AusperBio Announces Promising Phase II Clinical Data of AHB-137 in Treatment-Naïve Chronic Hepatitis B Patients at EASL 2026

As a product based on AusperBio's independently developed innovative first-generation Med-Oligo™AHB-137, a candidate drug developed on the ASO technology platform, has previously demonstrated superior efficacy and a favorable safety profile in NA-experienced, HBeAg-negative patients. The newly presented study results further validate its therapeutic potential in treatment-naïve chronic hepatitis B (CHB) patients, a broad CHB patient population.

Led by The First Affiliated Hospital, Zhejiang University School of Medicine, this randomized, double-blind, placebo-controlled Phase II clinical trial enrolled treatment-naïve patients with chronic hepatitis B (CHB) with baseline HBsAg levels of 100–10,000 IU/mL and HBV DNA levels of 20–2,000 IU/mL. Subjects received once-weekly AHB-137 (300 mg) or placebo for 16 weeks, followed by a 24-week off-treatment follow-up period. The primary endpoint was Complete Response (CR) at the End of Treatment (EOT), defined as HBsAg <0.05 IU/mL and HBV DNA <10 IU/mL; clinical cure was defined as sustained CR 24 weeks after treatment cessation.

The study results indicate that AHB-137 monotherapy can rapidly and profoundly suppress HBV DNA replication. After 16 weeks of treatment, 100% of subjects achieved HBV DNA negativity (<10 IU/mL), demonstrating highly potent viral suppression.

Meanwhile, AHB-137 also demonstrated significant clearance of hepatitis B surface antigen (HBsAg): in the overall population with baseline HBsAg levels of 100–10,000 IU/mL, 76% of patients achieved HBsAg clearance at the end of treatment; among patients with baseline HBsAg ≤ 3,000 IU/mL, 84% achieved HBsAg clearance; in patients with baseline HBsAg > 3,000 IU/mL, HBsAg levels decreased by more than 4.5 log10 IU/mL in all cases, with 50% of patients achieving HBsAg clearance. Overall, 68% of patients achieved a complete response (CR) at the end of treatment (EOT).

Notably, 24 weeks post-treatment cessation, 32% of the overall population (i.e., baseline HBsAg 100–10,000 IU/mL) achieved a functional cure (FC). Among patients with baseline HBsAg 100–1,000 IU/mL, the functional cure rate was 70%. In patients with baseline HBsAg > 1,000 IU/mL, 33% attained a “partial cure” state (sustained HBV DNA suppression and HBsAg < 10 IU/mL).

Regarding safety, AHB-137 was generally well tolerated, consistent with previous study results. The vast majority of treatment-related adverse events (TRAEs) were Grade 1-2, primarily manifesting as injection site reactions and laboratory abnormalities. Reversible ALT/AST elevations accompanying the rapid decline in HBsAg were consistent with prior observations in the NA-treated population.

About AHB-137

AHB-137 is a novel unconjugated antisense oligonucleotide (ASO) drug developed by AusperBio based on its proprietary Med-Oligo™ technology platform. Currently under development as an investigational therapy, it aims to achieve a clinical cure for chronic hepatitis B. The drug features a triple mechanism of action and has demonstrated positive results in both preclinical and clinical trials. Relevant findings have been presented at prestigious international conferences, including EASL (2023–2025), AASLD (2024–2025), and APASL 2025. AHB-137 has completed global Phase I clinical trials and is currently concurrently advancing multiple global Phase II clinical trials alongside a Phase III clinical trial in mainland China.

AboutAusperBio

AusperBio is a clinical-stage innovative drug R&D company operating concurrently in China and the United States, dedicated to developing proprietary, targeted-delivery oligonucleotide therapeutics with first-in-class and best-in-class potential. AusperBio holds the proprietary Med-Oligo™ ASO patented technology platform, focusing on the functional cure of chronic hepatitis B (HBV) and highly efficient targeted therapies for liver diseases, while expanding targeted oligonucleotide treatments to novel extrahepatic targets. AusperBio’s strategy is to integrate its internationally leading Med-Oligo™ oligonucleotide technology with highly specific and efficient targeting capabilities to address a broad spectrum of currently unmet medical needs.

Source:

1.AusperBio