AusperBio Achieves Milestone with Phase IIb AHB-137 Trial Dosing Completion and Unblinding

AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. have recently announced substantial progress in their clinical development of AHB-137, an antisense oligonucleotide (ASO) designed for the functional cure of chronic hepatitis B (CHB). The company, recognized for its advanced biotechnology endeavors, has been conducting a Phase IIb study (CTR20242026) where AHB-137 was assessed over two different treatment durations: 24 weeks and 16 weeks. Each cohort consisted of 32 patients, with the shorter treatment duration including an initial 8-week double-blind placebo lead-in period. AusperBio has completed dosing for both cohorts and has subsequently unblinded the study.

The promising advancement of AHB-137 highlights AusperBio's dedication to finding a functional cure for CHB. Dr. Guofeng Cheng, Co-founder and CEO of AusperBio, expressed optimism regarding the efficacy data obtained thus far in the Phase IIb study. He also noted the continued tolerability of AHB-137 amongst patients, which is crucial for the treatment's success. This progress follows on from interim data from the Phase IIa study, which was presented at the 2024 AASLD Liver Meeting® in a late-breaking oral presentation, illustrating rapid advancement in AHB-137's clinical development. Dr. Cheng affirmed that this progress underscores AusperBio's capability and commitment to addressing the urgent, unmet need for a CHB functional cure.

Dr. Chris Yang, Co-founder and CSO of AusperBio, echoed Dr. Cheng's sentiments, emphasizing that the Phase IIb interim data further solidifies the exciting findings from the Phase IIa study presented at AASLD 2024, particularly in terms of HBsAg loss and seroconversion. AusperBio is preparing to submit the interim data to an international conference in the near future. The swift progress of the Phase IIb study has been made possible through the collaboration of principal investigators, clinical staff, study participants, and the dedicated AusperBio team. The company extends its gratitude to all who have contributed to this achievement.

AHB-137, developed using AusperBio's proprietary Med-Oligo™ ASO technology platform, is an innovative unconjugated antisense oligonucleotide aimed at treating chronic hepatitis B for a functional cure. The treatment's impactful preclinical and Phase 1 clinical data were showcased at the 2023 and 2024 EASL™ conferences. This groundbreaking dual-mechanism ASO is currently undergoing a Phase 1b trial at various international study sites and two concurrent Phase 2 trials in China. In line with a global development strategy, AHB-137 is advancing swiftly toward the goal of curing HBV.

AusperBio, a clinical-stage biopharmaceutical company operating in the USA and China, is devoted to advancing oligonucleotide and targeted delivery technologies for transformative therapies. The company's initial focus is on curing chronic hepatitis B infection. AusperBio's proprietary Med-Oligo™ ASO platform significantly enhances current ASO therapeutics through innovative insights into ASO design. When combined with efficient targeted delivery conjugation technologies, the modular Med-Oligo™ Platform empowers ASO therapeutics to address a wide array of diseases, including viral infections, metabolic conditions, genetic disorders, and immune diseases.