AusperBio's ASO Drug AHB-137 for Functional Cure of Chronic Hepatitis B Granted Breakthrough Therapy Designation in China

Jul 04, 2024 07:21 CST Updated 07:21

AusperBio

Biological Vaccine and Nucleic Acid Drug Developer

July 4, 2024

eMedClub News

On July 3, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration disclosed that Hangzhou AusperBio Co., Ltd. (referred to as "AusperBio")...AusperBio"") Declaration ofABH-131 Injection Proposed for Inclusion in Breakthrough Therapy DesignationList. Information shows that this productIntended for the treatment of patients with chronic hepatitis B。

▲ Screenshot source: CDE official website

Hepatitis B is a type of infectious hepatitis induced by the Hepatitis B Virus (HBV),HBV infection is a major public health issue worldwide, with approximately 290 million people infected with HBV globally.HBV can be transmitted through mother-to-child, sexual contact, bodily fluids, and other routes. According to the Primary Care Guidelines for Chronic Hepatitis B, chronic hepatitis B virus infection refers to persistent infection with a positive hepatitis B surface antigen (HBsAg and/or HBV DNA) for more than six months.

Chronic hepatitis B can lead toCirrhosis and other chronic complications such as liver cancer. Current treatments can usually only suppress the replication of the hepatitis B virus, and there is an urgent clinical need for innovative therapies that can achieve functional cures for hepatitis B. Currently, antiviral drugs for chronic hepatitis B mainly include nucleos(t)ide analogs and interferon-based drugs (primarily pegylated interferon). For the vast majority of patients,Nucleos(t)ide analogs require lifelong medication, and patient compliance is relatively poor.

AHB-137 is aNaked Antisense Oligonucleotide (ASO) with the Potential to Become a Cornerstone for Functional Cure of Chronic Hepatitis B, is the first innovative drug under AusperBio's self-developed platform Med-Oligo to enter clinical trials,It is a non-conjugated antisense oligonucleotide (ASO) targeting all HBV RNA.The Med-Oligo ASO technology platform owned by the company enables highly efficient targeted treatment for liver diseases and is expanding its potential to new targets beyond the liver.

▲ Screenshot source: AusperBio official website

As of February this year, the phase 1a/1b clinical trial of AHB-137 for chronic hepatitis B has completed single-dose or multi-dose clinical administration in 122 subjects (including healthy subjects and 30 patients with chronic hepatitis B). The cohorts of 150mg and 300mg in the clinical trial conducted in China have completed recruitment of patients with chronic hepatitis B. In the clinical trials for chronic hepatitis B being conducted in the United States and New Zealand, six subjects with chronic hepatitis B have completed four weeks of dosing.

The types of CHB cure mainly include complete cure (also known as virological cure) and clinical cure (also known as functional cure or immunological cure). Functional cure refers to the sustained undetectability of serum HBsAg and HBV DNA, HBeAg seroconversion, with or without HBsAg serological conversion after completion of a finite course of treatment, while residual cccDNA may persist.Alleviation of liver inflammation and improvement in hepatic histopathology significantly reduce the incidence of end-stage liver disease.. Clinical cure is similar to the state of spontaneous viral clearance after acute HBV infection, markingDurable Immunological Control of CHB。

AusperBio is a clinical-stage innovative drug development company operating simultaneously in China and the United States, committed to researching and developing "First-in-class" and "Best-in-class" proprietary innovative targeted delivery drugs. AusperBio owns the proprietary intellectual property rights to the Med-Oligo™ ASO patent technology platform, focusing on functional cures for chronic hepatitis B (HBV) and highly efficient targeted treatments for liver diseases. Its strategy is to combine its leading Med-Oligo™ oligonucleotide technology with specific and highly efficient targeting technologies to address a wide range of currently unmet medical needs.

References:

1.https://www.cde.org.cn/main/xxgk/listpage/b40868b5e21c038a6aa8b4319d21b07d

2.https://cn.ausperbio.com/news/1798311893196169218.html

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