AusperBio Announces Breakthrough Therapy Status for AHB-137 in the Management of Chronic Hepatitis B
AusperBio Therapeutics and Ausper Biopharma have announced that their investigational drug, AHB-137, has received Breakthrough Therapy Designation (BTD) from the Centre for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. This designation aims to accelerate the development of AHB-137 and improve patient access to this therapy for chronic hepatitis B (CHB) infection.
The BTD is supported by clinical evidence from two parallel trials assessing the safety and efficacy of AHB-137 in CHB patients. These include a Phase 1/2a trial conducted in China and a Phase 1 trial carried out outside China.
This designation provides AHB-137 with an expedited review process by the CDE, facilitating timely communication and potential approval to meet significant clinical needs, although it does not alter product approval standards.
The Breakthrough Therapy Designation (BTD) is part of the revised Drug Registration Regulation. This programme aims to fast-track the development and evaluation of medicines for serious or life-threatening conditions, based on initial clinical evidence suggesting that the investigational therapy may significantly improve upon existing treatments for at least one important clinical endpoint.
About AHB-137
AHB-137 is an innovative unconjugated antisense oligonucleotide developed using AusperBio's proprietary Med-Oligo™ ASO technology platform, aimed at achieving a functional cure for chronic hepatitis B. The drug's promising preclinical data was presented at the 2023 EASL conference. Currently, AHB-137 is undergoing a Phase 1b trial at multiple international sites and a Phase 2 trial in China, advancing rapidly towards the goal of curing HBV through a global development strategy.
About Chronic Hepatitis B
Chronic hepatitis B is a liver disease that affects an estimated 290 million people worldwide and is a significant contributor to severe liver diseases, such as cirrhosis and hepatocellular carcinoma. Although current treatments can suppress HBV replication, achieving a cure remains rare, making the search for a definitive treatment an urgent medical priority.
