• 13 Jul 2024
• Admin
• News Article

China NMPA Grants BTD to AusperBio’s AHB-137

China NMPA grants Breakthrough Therapy Designation to AusperBio’s AHB-137 in chronic hepatitis B treatment

Overview

AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. (collectively AusperBio), a clinical-stage biotechnology company dedicated to advancing targeted oligonucleotide therapies for achieving functional cure in chronic hepatitis B (CHB) infection, announced that their investigational drug AHB-137 has received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. This designation accelerates AHB-137's development and potential access for patients.

BTD

• The BTD was supported by clinical evidence from two parallel trials evaluating AHB-137's safety and efficacy in treating CHB patients, a phase 1/2a trial conducted in China (chinadrugtrials.org.cn #CTR20232098; clinicaltrials.gov #NCT06115993) and a Phase 1 trial conducted outside China (clinicaltrials.gov #NCT05717686).
• Results from these trials were presented in two late-breaker posters at the European Association for the Study of the Liver (EASL) Congress 2024 in Milan, Italy.

From Regulatory Affairs Director at Ausperbio

• Bella Lu, regulatory affairs director at AusperBio, underscored that the BTD provides AHB-137 with expedited review status by the CDE, enabling timely communication and accelerated approval to address critical clinical needs. BTD does not change product approval standards but significantly expedites the regulatory process.
• "We are delighted by the NMPA's grant of Breakthrough Therapy Designation for AHB-137. This approval recognizes the promising clinical data collected to date and highlights the urgent need for substantial advancements in CHB treatment options," said Bella Lu. 
• "The outstanding safety and efficacy results from our phase 1/2a studies suggest that AHB-137 has the potential to improve upon current HBV therapies. With NMPA's support, we aim to accelerate AHB-137's development further."

NMPA BTD Programme

• The Breakthrough Therapy Designation (BTD) is part of the recently revised Drug Registration Regulation, effective from July 1, 2020. 
• The NMPA BTD programme aims to accelerate the development and evaluation of medicines for serious or life-threatening diseases. 
• This designation is granted based on preliminary clinical evidence indicating that the investigational therapy may offer substantial improvement over available therapies on at least one clinically significant endpoint.

About AHB-137

• AHB-137, a novel unconjugated antisense oligonucleotide (ASO) developed within AusperBio's proprietary Med-Oligo ASO technology platform, was designed to treat chronic hepatitis B for a functional cure. 
• Its compelling preclinical data was highlighted at the 2023 EASL conference. 
• This novel dual-mechanism ASO is presently undergoing concurrent a Phase 1b trial across multiple international study sites and a Phase 2 trial in China. 
• Through a global development strategy, AHB-137 is advancing rapidly towards the goal of HBV cure.
• Chronic hepatitis B infection
• Chronic hepatitis B infection is a liver disease estimated to affect nearly 290 million people worldwide and is a leading cause of major liver diseases such as liver cirrhosis and hepatocellular carcinoma. 
• Although current treatment options can suppress HBV replication, achieving a cure is rare. Therefore, the discovery of a cure for CHB with finite treatment is a serious and urgent medical need.

About AusperBio

AusperBio is a clinical-stage biopharmaceutical company with operations in the USA and China, dedicated to advancing oligonucleotide and targeted delivery technologies for transformative therapies, with an initial focus on curing chronic hepatitis B infection.