AusperBio AHB-137 Secures Breakthrough Status in China for CHB

AusperBio Therapeutics and Ausper Biopharma have recently received breakthrough therapy designation (BTD) from the National Medical Products Administration (NMPA) of China for their investigational drug, AHB-137, designed to treat chronic hepatitis B (CHB). This designation is intended to speed up the development and review process of AHB-137, which represents a novel therapeutic option for individuals suffering from CHB.

The decision to grant BTD was influenced by positive clinical data obtained from two parallel clinical trials. These trials evaluated the safety and efficacy of AHB-137 in treating CHB. One of the trials, a Phase I/IIa study, was conducted in China, and the other, a Phase I trial, was carried out at an international location.

AHB-137 is an unconjugated antisense oligonucleotide, developed using AusperBio’s Med-Oligo ASO technology platform. This innovative drug aims to achieve a functional cure for CHB through a dual-mechanism approach that has shown promising results in preclinical studies.

Currently, AHB-137 is undergoing further evaluation in a Phase Ib trial at multiple international sites and a Phase II trial in China. These trials are critical steps in confirming the drug’s potential and ensuring its safety and effectiveness for wider use.

Bella Lu, the director of regulatory affairs at AusperBio, emphasized that the breakthrough therapy designation does not lower the standards required for product approval. Instead, it facilitates a more efficient regulatory process. Lu expressed the company’s gratification over the NMPA’s decision to grant this designation, recognizing the promising clinical data gathered thus far and the urgent need for more effective CHB treatments.

Lu highlighted the impressive safety and efficacy outcomes from the Phase I/IIa trials, suggesting that AHB-137 could significantly improve upon existing hepatitis B virus (HBV) therapies. With the support of the NMPA, AusperBio is determined to accelerate the development of AHB-137, aiming to bring this potentially groundbreaking treatment option to patients more swiftly.

In summary, the breakthrough therapy designation granted to AHB-137 by China’s NMPA is a significant milestone for AusperBio Therapeutics and Ausper Biopharma. It underscores the potential of AHB-137 to transform the treatment landscape for chronic hepatitis B, promising a new avenue of hope for patients grappling with this chronic condition.