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-Oligo^TM 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-Oligo^TM 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.

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SOURCE AusperBio Therapeutics Inc.