eClinical Technology and Industy News

AusperBio Announces FDA Clearance of IND Application of AHB-137 in Chronic Hepatitis B Treatment

  • AHB-137 is cleared for initiation of a clinical trial in CHB patients in the US
  • AHB-137 is an unconjugated antisense oligonucleotide (ASO) aimed for functional cure of CHB

Excerpt from the Press Release:

SAN FRANCISCO, Aug. 25, 2023 /PRNewswire/ — AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. (Together AusperBio), a clinical-stage biotech company committed to advancing antiviral therapies and vaccines, with a primary focus on achieving a functional cure for chronic hepatitis B (CHB) infection, today announced the U.S. Food and Drug Administration (FDA) has granted clearance for the Investigational New Drug (IND) application for a clinical trial on AHB-137. The clinical trial in the US is part of a multiregional, randomized, double-blinded, placebo-controlled study, intended to assess the safety, tolerability, pharmacokinetics, and initial efficacy of AHB-137 in CHB patients ( # NCT05717686).

“The FDA’s clearance of our IND application to initiate clinical evaluation of AHB-137 in CHB patients in the United States brings us one step closer to introducing a potential functional cure for people living with HBV.” said AusperBio CEO and Co-founder Dr. Guofeng Cheng, “This milestone is a pivotal juncture for AusperBio, underscoring our consistent and outstanding execution in driving innovative therapies towards a functional cure for CHB.”

“We are committed to expediting patient access to innovative treatments.” Dr. Cheng Yong Yang, CSO and Co-founder of AusperBio highlighted. “Our focus now is on working closely with key opinion leaders to initiate the CHB patient study in the US.”

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