AusperBio's AHB-137 Granted Breakthrough Therapy for Chronic Hepatitis B

AusperBio Therapeutics, Inc. and its counterpart Ausper Biopharma Co., Ltd. (collectively known as AusperBio) have announced that their experimental drug, AHB-137, has earned Breakthrough Therapy Designation (BTD) from the Chinese National Medical Products Administration (NMPA). This designation is poised to expedite the development and regulatory review of AHB-137, offering a potential lifeline for those suffering from chronic hepatitis B (CHB), a condition affecting approximately 296 million individuals globally and serving as a primary cause of liver cancer.

The decision to grant BTD to AHB-137 was fueled by positive clinical data from two separate trials. One Phase 1/2a trial was conducted in China, while a Phase 1 trial took place internationally. The results from these studies were showcased in late-breaking posters at the European Association for the Study of the Liver (EASL) Congress 2024 in Milan, Italy. The designation is expected to accelerate AHB-137's pathway to approval, making it more readily available to patients in critical need of new treatment options.

Bella Lu, Regulatory Affairs Director at AusperBio, emphasized the significance of this designation, noting that while it doesn't alter the product approval standards, it does accelerate the overall regulatory process. Lu expressed optimism about the promising clinical data gathered thus far, which suggests that AHB-137 could offer substantial improvements over existing HBV therapies. With the backing of the NMPA, AusperBio aims to expedite the development of AHB-137 to meet the urgent clinical needs of patients.

The NMPA's Breakthrough Therapy Designation (BTD) is part of China's updated Drug Registration Regulation, effective from July 1, 2020. This designation is aimed at accelerating the development and review of drugs for serious or life-threatening conditions. It is granted based on preliminary clinical evidence showing that the investigational therapy could provide significant improvements over current treatments in at least one clinically meaningful endpoint.

AHB-137 is a novel unconjugated antisense oligonucleotide (ASO) developed under AusperBio's proprietary Med-Oligo™ ASO technology platform. Designed to achieve a functional cure for chronic hepatitis B, AHB-137 has demonstrated compelling preclinical data, which was highlighted at the EASL conference in 2023. The drug is currently undergoing a Phase 1b clinical trial at multiple international sites and a Phase 2 trial in China. AusperBio is pursuing a global development strategy to advance AHB-137 rapidly towards its goal of curing HBV.

Chronic hepatitis B is a severe liver disease impacting nearly 290 million people worldwide. It is a leading cause of significant liver conditions such as liver cirrhosis and hepatocellular carcinoma. While current treatments can suppress HBV replication, a cure remains rare, highlighting the urgent need for effective treatments that can offer a finite solution.

AusperBio is a clinical-stage biopharmaceutical company operating in the USA and China. The company focuses on advancing oligonucleotide and targeted delivery technologies to develop transformative therapies, with an initial focus on curing chronic hepatitis B. Their proprietary Med-Oligo™ ASO platform has shown significant advancements over existing ASO therapeutics, offering new insights into ASO design and efficient targeted delivery. This modular platform enables the treatment of a wide range of diseases, including viral infections, metabolic conditions, genetic disorders, and immune diseases.