AusperBio Showcases Key Progress in AHB-137 Clinical Trials

AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd., collectively known as AusperBio, have announced notable advancements in the clinical development of AHB-137, their leading therapeutic candidate aimed at achieving a functional cure for chronic hepatitis B (CHB) infection. This promising treatment is an unconjugated antisense oligonucleotide (ASO) that targets all HBV mRNA, presenting itself as a potential cornerstone for new CHB therapies.

Key milestones in the development of AHB-137 include the enrollment of 193 participants, among which 101 are CHB patients, in clinical studies. This participation has provided extensive data on the drug's safety and efficacy. Notably, the Phase 1b study in China has been successfully completed, and global Phase 1b patient enrollment has also concluded. The clinical findings from these Phase 1 studies were showcased in two late-breaking posters at the European Association for the Study of the Liver (EASL) 2024 conference. Additionally, the Phase 2a study in China has finished patient enrollment, and large-scale manufacturing of the AHB-137 drug product has been completed.

Dr. Guofeng Cheng, Co-founder and CEO of AusperBio, expressed his enthusiasm regarding these clinical milestones achieved in the first half of 2024. He highlighted the significant recognition of AHB-137's safety and potency profile at the EASL 2024 in Milan and emphasized the importance of successful large-scale manufacturing for the drug's clinical development. Dr. Cheng also acknowledged the support from principal investigators, clinical staff, the AusperBio team, and the study participants.

Dr. Chris Yang, Co-founder and CSO of AusperBio, added that the rapid completion of Phase 2a enrollment positions the company on an accelerated timeline to confirm AHB-137's safety and efficacy profile for treatments extending beyond four weeks. He expressed optimism regarding the emerging data and mentioned plans to present an interim data analysis at a major international conference later this year.

AHB-137, developed within AusperBio's proprietary Med-Oligo™ ASO technology platform, is designed to treat chronic hepatitis B with the aim of achieving a functional cure. The preclinical data for AHB-137 was prominently featured at the 2023 EASL conference. This unique dual-mechanism ASO is currently undergoing a Phase 1b trial at multiple international sites and a Phase 2 trial in China. The global development strategy for AHB-137 is progressing rapidly towards the goal of curing HBV.

Chronic hepatitis B is a liver disease that affects close to 290 million people worldwide and is a leading cause of severe liver conditions such as cirrhosis and hepatocellular carcinoma. Current treatments can suppress HBV replication but rarely result in a cure, underscoring the urgent need for a finite treatment that achieves a cure for CHB.

AusperBio is a clinical-stage biopharmaceutical company with operations in the USA and China, focused on advancing oligonucleotide and targeted delivery technologies for transformative therapies, primarily targeting chronic hepatitis B infection. The company's proprietary Med-Oligo™ ASO platform enhances current ASO therapeutics through innovative design insights. Coupled with efficient targeted delivery conjugation technologies, this platform empowers ASO therapeutics to address a wide array of diseases, including viral infections, metabolic conditions, genetic disorders, and immune diseases.