AusperBio Reaches Key Milestone with Dosing Completion and Study Unblinding in Ongoing AHB-137 Phase IIb Trial

SAN FRANCISCO, Feb. 11, 2025 /PRNewswire/ -- AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. (together AusperBio), a clinical-stage biotechnology company, today announced recent progress in the ongoing clinical development of its lead candidate AHB-137, an antisense oligonucleotide (ASO) therapeutic for functional cure of chronic Hepatitis B (CHB).

In the Phase IIb study (CTR20242026), AHB-137 was evaluated across two treatment durations—24 weeks and 16 weeks—each enrolling 32 patients. The 16-week cohort included an initial 8-week double-blind placebo lead-in period. AusperBio is pleased to report that dosing in both cohorts has now been completed, and the study has been unblinded.

"We are highly encouraged by the efficacy data observed in the Phase IIb study thus far. As importantly, AHB-137 has continued to be well tolerated in patients." said Dr. Guofeng Cheng, Co-founder and CEO of AusperBio. " This progress comes on the heels of the interim Phase IIa study data presented in a late-breaking oral presentation at the 2024 AASLD Liver Meeting®. The rapid progress in AHB-137's clinical development is a testament to AusperBio's capability and commitment to addressing the urgent unmet need of a CHB functional cure."

Dr. Chris Yang, Co-founder and CSO of AusperBio, added, "The Phase IIb interim data strengthens the exciting Phase IIa data presented at AASLD 2024, in terms of both HBsAg loss and seroconversion. We are working towards submitting the interim data to an international conference shortly."

The rapid progress of Phase IIb study would not have been possible without the efforts of principal investigators, clinical staff, study participants, and our dedicated AusperBio team members. The company extends its sincere gratitude to everyone involved in making this progress possible.

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 and Phase 1 clinical data was highlighted at the 2023 EASL™ conference and the 2024 EASL™ conference, respectively. This novel dual-mechanism ASO is presently undergoing a Phase 1b trial across multiple international study sites and two concurrent Phase 2 trials in China. Through a global development strategy, AHB-137 is advancing rapidly towards the goal of HBV cure.

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. The company has developed a proprietary Med-Oligo™ ASO platform which has been shown to substantially enhance the current ASO therapeutics, through novel insights into ASO design. Combining with efficient targeted delivery conjugation technologies, the modular Med-Oligo™ Platform empowers ASO therapeutics to treat a broad range of diseases, including viral infections, metabolic conditions, genetic disorders, and immune diseases. For more information, visit www.ausperbio.com

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SOURCE AusperBio Therapeutics Inc.