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).