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 (clinicaltrials.gov # 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.”
About Chronic Hepatitis B
Chronic Hepatitis B (CHB) infection is a liver disease estimated to affect nearly 290 million people worldwide and can cause other chronic complications such as 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 remains an urgent need.