Pharma Focus Asia

AusperBio Announces Investigational New Drug Application Approval of AHB-137

Thursday, June 29, 2023

AusperBio Therapeutic and Ausper Biopharma announced that the Centre for Drug Evaluation (CDE) in China has granted approval for the Investigational New Drug (IND) application of AHB-137 as a potential treatment for chronic hepatitis B (CHB), with the goal of achieving a functional cure.

AHB-137. AHB-137 is an unconjugated antisense oligonucleotide (ASO) that holds potential as a foundational component for achieving a functional cure for chronic hepatitis B (CHB). 

The clinical trial protocol CXHL2300362, which has received approval, is a phase I study designed as a randomised, double-blind, placebo-controlled trial. Its primary objectives are to assess the safety, tolerability, pharmacokinetics, and initial antiviral activity of AHB-137.

The approval of AHB-137's Investigational New Drug (IND) application by the Centre for Drug Evaluation (CDE) of China represents a significant milestone in its clinical development. This achievement is expected to have several positive effects on the progress of AHB-137 and the broader field of innovative therapies for the functional cure of chronic hepatitis B (CHB).

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