#USA #San Francisco #AusperBio #AHB-137 #Chronic Hepatitis B

AusperBio Achieves Enrollment Milestone in Phase III AUSHINE Study

AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd., collectively known as AusperBio, report that they have successfully completed patient enrollment for their pivotal Phase III clinical trial, termed AUSHINE Study. This significant study focuses on AHB-137, a novel therapy aimed at managing chronic hepatitis B (CHB).

Overview of the AUSHINE Study

The AUSHINE trial is a crucial randomized, double-blind, multicenter study designed to assess the efficacy and safety of AHB-137 in patients who have HBeAg-negative chronic hepatitis B and are recipients of nucleos(t)ide analogue (NA) therapy. Chronic hepatitis B continues to pose a serious public health problem worldwide, with approximately 254 million individuals estimated to be living with a hepatitis B virus (HBV) infection, according to the World Health Organization's Global Hepatitis Report 2024. Alarmingly, China accounts for roughly 75 million chronic infections.

Expert Commentary

Professor Jian Sun, the principal investigator from Nanfang Hospital of Southern Medical University, emphasized the importance of this study, stating, "For the majority of patients dealing with HBeAg-negative CHB, current treatment methods only provide suppressive relief rather than a cure. Thus, achieving a functional cure is a critical unmet need for a significant patient demographic, many of whom are left under ongoing treatment with the risk of disease escalation. Hence, completing enrollment for this Phase III study marks an important milestone in bridging this therapeutic gap."

Dr. Guofeng Cheng, Co-founder and CEO of AusperBio, expressed satisfaction with the timely completion of the enrollment, noting, "We managed to recruit over 570 patients, surpassing our timeline expectations. This incredible accomplishment was made possible by the remarkable cooperation and commitment of our investigators, clinical teams, and the patients involved. Our unwavering commitment lies in rigorously advancing AHB-137 down the regulatory pathway, with a keen focus on delivering transformative treatment options for those affected by chronic hepatitis B."

The Significance of AHB-137

AHB-137 is a cutting-edge unconjugated antisense oligonucleotide developed through AusperBio's proprietary Med-Oligo™ ASO technology platform. It is designed specifically to achieve functional cure for chronic hepatitis B by targeting the suppression of HBsAg at the transcriptional level, inhibiting viral DNA replication, and triggering immune responses. In early-stage studies, AHB-137 exhibited promising results, showing a functional cure rate of around 30%, a statistic recently highlighted during the HEP-DART 2025 conference.

Dr. Chris Yang, Co-founder and Chief Scientific Officer of AusperBio, shared insights on the project's progress, stating, "The rapid enrollment completion of the Phase III AUSHINE study demonstrates our readiness to take the next steps toward evaluating the treatment's primary endpoint outcomes. The interest shown by clinical sites, combined with the observational clinical efficacy thus far, intensifies the urgency for innovative HBV therapies and fortifies our confidence in AHB-137's potential to yield functional cures for patients with chronic hepatitis B."

Conclusion

With the completion of patient enrollment in the AUSHINE study, AusperBio is poised to continue its mission of transforming chronic hepatitis B treatment paradigms. As this advanced therapy progresses, the hope remains that AHB-137 can bring a substantial change in the lives of the millions affected by chronic hepatitis B worldwide. Keep an eye on further developments from AusperBio and their innovations in therapeutic solutions.

For more information on AusperBio and their research, visit www.ausperbio.com.