AusperBio Highlights Major Advances in AHB-137 Clinical Development

SAN FRANCISCO, July 5, 2024 /PRNewswire/ — AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. (collectively AusperBio), a clinical-stage biotechnology company dedicated to advancing targeted oligonucleotide therapies, with the goal of achieving functional cure for chronic hepatitis B (CHB) infection, today announced significant progress in the clinical development of its leading candidate, AHB-137. This innovative unconjugated antisense oligonucleotide (ASO) targets all HBV mRNA, positioning it as a potential backbone of novel therapies to treat CHB for functional cure.

Key Clinical Development Highlights:

As of the report date, a total of 193 participants, including 101 CHB patients, have been enrolled in the AHB-137 clinical studies, generating a substantial dataset for the drug’s safety and efficacy profile, and marking significant progress since our last update in February.

China Phase 1b study has been successfully completed.Global Phase 1b patient enrollment has concluded. Clinical data from both Phase 1 studies were presented in two late-breaker posters at EASL 2024. Phase 2a study in China has completed patient enrollment.Large-scale manufacturing of AHB-137 drug product has been successfully completed.

“We are extremely excited by the clinical milestones the AHB-137 program has achieved in the first half of 2024,” said Dr. Guofeng Cheng, Co-founder and CEO of AusperBio. “The safety and potency profile of AHB-137 garnered significant recognition at EASL 2024 in Milan. The success of CMC will further enable our clinical development for AHB-137. I am deeply grateful for the immense support from our principal investigators, clinical staff, the AusperBio team, and the study participants.”

Dr. Chris Yang, Co-founder and CSO of AusperBio, added, “The rapid completion of Phase 2a enrollment positions us on an accelerated timeline to establish AHB-137’s safety and efficacy profile for treatments beyond four weeks. We are very encouraged by the emerging data and plan to present an interim data analysis at a major international conference later this year.”

About AHB-137

AHB-137, a novel unconjugated antisense oligonucleotide (ASO) developed within AusperBio’s proprietary Med-Oligo™ ASO technology platform, was designed to treat chronic hepatitis B for a functional cure. Its compelling preclinical data was highlighted at the 2023 EASL™ conference. This novel dual-mechanism ASO is presently undergoing concurrent a Phase 1b trial across multiple international study sites and a Phase 2 trial in China. Through a global development strategy, AHB-137 is advancing rapidly towards the goal of HBV cure.

About Chronic Hepatitis B

Chronic Hepatitis B infection is a liver disease estimated to affect nearly 290 million people worldwide and is a leading cause of major liver diseases such as liver cirrhosis and hepatocellular carcinoma. Although current treatment options can suppress HBV replication, achieving a cure is rare. Therefore, the discovery of a cure for CHB with finite treatment is a serious and urgent medical need.

About AusperBio

AusperBio is a clinical-stage biopharmaceutical company with operations in the USA and China, dedicated to advancing oligonucleotide and targeted delivery technologies for transformative therapies, with an initial focus on curing chronic hepatitis B infection. The company has developed a proprietary Med-OligoTM ASO platform which has been shown to substantially enhance the current ASO therapeutics, through novel insights into ASO design. Combining with efficient targeted delivery conjugation technologies, the modular Med-OligoTM Platform empowers ASO therapeutics to treat a broad range of diseases, including viral infections, metabolic conditions, genetic disorders, and immune diseases. For more information, visit www.ausperbio.com.

For further information, please contact:

Media Contact
Email: info@ausperbio.com

Investor Relations Contact:
Tel: 650-888-1756 (US)
Email: growth@ausperbio.com

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SOURCE AusperBio Therapeutics Inc.