Tuesday, 02 January 2024 12:17 GMT

Ausperbio Highlights Major Advances In AHB-137 Clinical Development


Date:

(MENAFN- PR Newswire) 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.

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Key Clinical Development Highlights:

CHB, HBV functional cure, ASO, AHB-137, clinical trials

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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-OligoTM ASO technology platform, was designed to treat chronic hepatitis B for a functional cure. Its compelling preclinical data
was highlighted at the 2023 EASLTM 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 .

For further information, please contact:

Media Contact
Email:
[email protected]

Investor Relations Contact:
Tel: 650-888-1756 (US)
Email:
[email protected]

SOURCE AusperBio Therapeutics Inc.

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