AusperBio Therapeutics, Inc. announced today the completion of dosing and study unblinding in the Phase IIb clinical trial of its lead candidate AHB-137, marking a significant milestone in the development of a potential functional cure for chronic Hepatitis B (CHB).
The Phase IIb study (CTR20242026) evaluated AHB-137, an antisense oligonucleotide (ASO) therapeutic, in two distinct treatment arms. The trial enrolled 32 patients in each cohort, with one group receiving treatment for 24 weeks and another for 16 weeks. The 16-week cohort incorporated an 8-week double-blind placebo lead-in period to establish baseline comparisons.
Clinical Progress and Initial Findings
Dr. Guofeng Cheng, Co-founder and CEO of AusperBio, expressed optimism about the trial results: "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." The development follows the company's recent presentation of interim Phase IIa study data at the 2024 AASLD Liver Meeting®.
Dr. Chris Yang, Co-founder and CSO, highlighted the strengthening evidence for the drug's potential: "The Phase IIb interim data strengthens the exciting Phase IIa data presented at AASLD 2024, in terms of both HBsAg loss and seroconversion." The company plans to submit the interim data to an international conference in the near future.
Innovative Technology Platform
AHB-137 represents a novel approach to treating chronic hepatitis B, utilizing AusperBio's proprietary Med-Oligo™ ASO technology platform. The drug employs a dual-mechanism approach and has shown compelling results in both preclinical studies and Phase 1 clinical trials, which were presented at the 2023 and 2024 EASL™ conferences.
Global Development Strategy
The company is pursuing an aggressive development timeline with multiple concurrent trials. In addition to the Phase IIb study, AHB-137 is currently being evaluated in a Phase 1b trial across multiple international study sites and two Phase 2 trials in China. This multi-pronged approach demonstrates AusperBio's commitment to expediting the development of a functional cure for chronic hepatitis B.
The successful completion of this Phase IIb trial milestone represents a collaborative achievement, involving principal investigators, clinical staff, study participants, and the AusperBio team. The company continues to advance its mission of developing transformative therapies through oligonucleotide and targeted delivery technologies, with a primary focus on addressing the significant unmet need for a chronic hepatitis B cure.
