- AHB-137 approved to initiate clinical trial in patients with chronic hepatitis B in U.S.
- AHB-137 is a non-conjugated antisense oligonucleotide (ASO) designed to functionally cure CHB
san francisco, August 25, 2023 /PRNewswire/—— AusperBio Therapeutics, Inc..and Osper Biopharmaceutical Co., Ltd.. (Together Osbo Biotechnology), a clinical-stage biotechnology company advancing antiviral therapies and vaccines with a primary focus on achieving a functional cure for chronic hepatitis B (CHB) infection, announced today The U.S. Food and Drug Administration (FDA) has approved the investigational new drug (IND) application for AHB-137.. The U.S. clinical trial is part of a multiregional, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics and initial efficacy of AHB-137 in patients with CHB (clinicaltrials. gov #NCT05717686).
“FDA approves our IND application to initiate clinical evaluation of AHB-137 in patients with chronic hepatitis B USA Bringing us one step closer to bringing a potential functional cure to people living with hepatitis B virus. “AusperBio CEO and Co-Founder Dr. Cheng Guofeng”, “This milestone is a critical moment for AusperBio and underscores our consistent and outstanding execution in advancing innovative therapies to achieve a functional cure for CHB. “
“We are committed to accelerating patient access to innovative treatments.” Dr. Cheng Yongyang, CSO and co-founder of AusperBio emphasized. “Our focus now is to work closely with key opinion leaders to initiate studies in patients with chronic hepatitis B in the United States.”
About chronic hepatitis B
Chronic hepatitis B (CHB) infection is a liver disease estimated to affect nearly 290 million people worldwide and may lead to other chronic complications such as cirrhosis and hepatocellular carcinoma. Although current treatment options can suppress hepatitis B virus replication, cure is rare. Therefore, finding a cure for chronic hepatitis B remains a top priority.
AusperBio is a clinical-stage biopharmaceutical company with operations in the United States and China, dedicated to developing innovative treatments for chronic hepatitis B.The company has developed a proprietary Med-Oligo™ ASO Technology Platform, greatly enhances the effectiveness of targeted therapies not only for liver disease but also has the potential to expand beyond the liver. AusperBio’s strategy is to combine its leading oligonucleotide therapeutics with other medicines, including therapeutic antibodies and mRNA vaccines, to address a broad range of unmet medical needs.
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SOURCE AusperBio Therapeutics Inc.