AusperBio's AHB-137 Receives Breakthrough Therapy Designation for Chronic Hepatitis B Treatment
Thursday, July 11, 2024
AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. (collectively AusperBio) have announced that their investigational drug AHB-137 has received Breakthrough Therapy Designation (BTD) from the National Medical Products Administration (NMPA) of China. This designation is intended to accelerate the development and potential approval of AHB-137, an oligonucleotide therapy designed to achieve a functional cure for chronic hepatitis B (CHB) infection.
The BTD follows positive clinical evidence from two parallel trials evaluating AHB-137's safety and efficacy. These trials include a Phase 1/2a trial in China and a Phase 1 trial conducted internationally, with results presented at the 2024 European Association for the Study of the Liver (EASL) Congress in Milan, Italy.
AusperBio highlighted that the BTD status enables expedited review processes by the NMPA, facilitating swift communication and potential approval to address critical clinical needs. While BTD does not change approval standards, it significantly speeds up regulatory timelines.
"We are pleased with the NMPA's decision to grant Breakthrough Therapy Designation for AHB-137," said Bella Lu. "This acknowledgment reflects the promising clinical data gathered to date and underscores the urgent need for advancements in CHB treatment options. The positive safety and efficacy outcomes from our Phase 1/2a studies suggest that AHB-137 has the potential to improve upon current HBV therapies. With the support of the NMPA, we aim to accelerate further development of AHB-137."
AHB-137, developed using AusperBio's Med-Oligo™ ASO technology platform, is an innovative antisense oligonucleotide (ASO) targeting chronic hepatitis B for a functional cure. It has shown promising preclinical data and is currently undergoing Phase 1b and Phase 2 trials globally. This global approach underscores its rapid advancement towards potentially curing HBV, addressing a significant medical need affecting approximately 290 million people worldwide.
Chronic Hepatitis B infection is a major global health concern, leading to severe liver diseases such as cirrhosis and liver cancer. While current treatments can suppress HBV replication, achieving a cure remains challenging, emphasizing the urgent need for effective therapies like AHB-137.
The NMPA's Breakthrough Therapy Designation program, implemented since July 1, 2020, aims to expedite the evaluation and development of medicines for serious or life-threatening conditions based on preliminary clinical evidence indicating potential significant improvement over existing therapies.
Source: prnewswire.com
