AusperBio Announces Significant Clinical Progress of AHB-137, an Antisense Oligonucleotide Drug for Functional Cure of Chronic Hepatitis B

Recently, AusperBio announced:Antisense Oligonucleotide Drug AHB-137 Achieves Significant Progress in Clinical Trials in China and Other Countries/Regions。

• Currently, 122 subjects, including 30 patients with chronic hepatitis B, have received AHB-137 dosing;

• In China, the chronic hepatitis B subjects in the 150mg and 300mg dose groups have successfully completed enrollment;

• In the United States and New Zealand, six subjects with chronic hepatitis B have completed a 4-week dosing period.

• The recovery period of the long-term toxicity study in cynomolgus monkeys has ended and histopathological examination has been completed.

  
  

AHB-137 is a cornerstone drug under AusperBio's proprietary Med-Oligo™ ASO patent technology platform, aimed at functionally curing chronic hepatitis B. Currently, the drug is undergoing concurrent Phase 1a/1b clinical trials in China and other countries and regions. As of the release date, a total of 122 subjects, including 30 patients with chronic hepatitis B, have received single or multiple doses of AHB-137. In China (chinadrugtrials.org.cn #CTR20232098; clinicaltrials.gov #NCT06115993), the dose escalation phase has successfully completed enrollment for two dose groups of 150mg and 300mg in subjects with chronic hepatitis B. Outside of China (clinicaltrials.gov #NCT05717686), dosing for subjects with chronic hepatitis B is also being accelerated concurrently. To date, six subjects have completed four weeks of dosing in the United States and New Zealand.

Dr. Guozheng Cheng, CEO & Co-founder of AusperBioStated: "The clinical progress of AHB-137 achieved in multiple countries and regions is truly exciting! This milestone marks AusperBio's entry into an entirely new phase of development. I am genuinely proud of our team for their united efforts and efficient execution in advancing the functional cure for chronic hepatitis B. At the same time, I would like to express my sincere gratitude to the clinicians, trial participants, clinical CROs, and other relevant partners who have made outstanding contributions to accelerating the clinical development of AHB-137!"

Dr. Chengyong Yang, CSO & Co-Founder of AusperBio"Not even a year has passed since the first human dosing, and AHB-137 has already achieved such incredible results, which is truly exciting for us. The preliminary efficacy data observed in patients with chronic hepatitis B has been highly encouraging! More importantly, being able to obtain such extensive safety data in such a short period of time has given us even greater confidence to continue accelerating the clinical trials of AHB-137! With the successful completion of 26-week long-term toxicity studies in cynomolgus monkeys and mice, we will rapidly advance AHB-137 into Phase II clinical trials. We eagerly look forward to presenting the detailed clinical research findings of AHB-137 at upcoming international conferences."

About Chronic Hepatitis B

HBV infection is a major public health issue worldwide, with approximately 290 million people infected globally, which can lead to cirrhosis, liver cancer, and other chronic complications. Current treatments generally only suppress the replication of the hepatitis B virus, and there is an urgent need for innovative therapies that can achieve functional cures for hepatitis B.

About AusperBio

AusperBio is an innovative drug research and development company at the clinical stage, operating simultaneously in China and the United States. It is committed to developing First-in-class and Best-in-class self-innovative targeted delivery small nucleic acid drugs. AusperBio owns the proprietary intellectual property rights of the Med-Oligo™ ASO patent technology platform, focusing on functional cures for chronic hepatitis B (HBV) and highly efficient targeted treatments for liver diseases, while expanding into therapies targeting new sites beyond the liver. AusperBio's strategy is to combine its leading Med-Oligo™ oligonucleotide technology with specific and highly efficient targeting technology to address a wide range of currently unmet medical needs.