AusperBio Announces IND Approval from China CDE for HBV ASO AHB-137

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Jun 28, 2023, 14:15 ET

SAN FRANCISCO, June 28, 2023 /PRNewswire/ -- AusperBio Therapeutic, Inc. and Ausper Biopharma Co., Ltd. (Together AusperBio), a clinical-stage biotech company announced that the Center for Drug Evaluation (CDE) of China has approved the Investigational New Drug (IND) application of AHB-137 to treat chronic hepatitis B (CHB) aiming for functional cure.

AHB-137 is an unconjugated antisense oligonucleotide (ASO) with the potential to be a backbone for the functional cure of CHB. The approved clinical trial protocol (CXHL2300362) is a randomized, double-blind, placebo-controlled phase I study to evaluate the safety, tolerability, pharmacokinetics, and initial antiviral activity of AHB-137 with single ascending doses and multiple ascending doses in healthy volunteers and chronic Hepatitis B Patients.

"We are thrilled to have received the IND approval from China CDE," said of Dr. Guofeng Cheng, CEO and Co-founder of AusperBio. "The approval will significantly propel the clinical development of AHB-137, which will foster collaborations with industry stakeholders, and accelerate the overall advancement of innovative therapies for functional cure of CHB."

Dr. Cheng Yong Yang, CSO and Co-founder of AusperBio, added "The IND approval represents a significant milestone in the clinical development of AHB-137. At the recently concluded EASL^™ congress, AHB-137's highly potent antiviral activity in preclinical studies, along with its favorable pharmacokinetics and safety profile, garnered significant attention and recognition. We are actively working on expediting the clinical studies of AHB-137 in multi-regional trial centers."

This approval from China CDE further solidifies the ASO Med-Oligo^™ platform of AusperBio, and it also signifies an important step in the field of hepatitis B treatment for functional cure. AusperBio will leverage the ongoing phase I clinical studies in New Zealand to drive efficient clinical trials of AHB-137 in China.

About Chronic Hepatitis B

Chronic Hepatitis B (CHB) is a liver disease estimated to affect nearly 290 million people worldwide and can cause other chronic complications such as cirrhosis and hepatocellular carcinoma. Current treatment is often able to suppress HBV replication, but discovery of a finite cure remains urgent need.

About AusperBio.

AusperBio is a clinical-stage biopharmaceutical company with operations in the USA and in China, dedicated to the development of innovative therapeutics for curing chronic hepatitis B. The company has developed a proprietary Med-Oligo^™ ASO technology platform, which has substantially empowered the potency of targeted therapies, not only for liver diseases, but also with the great potential for expansion beyond the liver. AusperBio's strategy is to combine its leading oligonucleotide therapies with other medications including therapeutic antibodies and mRNA vaccines to address a broad range of unmet medical needs.

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SOURCE AusperBio Therapeutics Inc.