Ausper Biopharma Co., Ltd. and AusperBio Therapeutic, Inc. (Together Ausperbio) today announced the completion of the first cohort dosing in a Phase 1 clinical trial evaluating AHB‑137 in adult healthy volunteers and chronic hepatitis B (CHB) patients in New Zealand. AHB-137 is a potential best-in-class, highly potent, pan-genotypic antisense oligonucleotide (ASO) targeting all HBV RNA for the treatment of CHB patients. AHB-137 has been well-tolerated in all human subjects in the first cohort.
“We are thrilled to initiate the first-in-human dosing of AHB-137 in New Zealand. ASO drug targeting HBsAg production has demonstrated great promise to become a cornerstone therapy to achieve functional cure of CHB. AHB-137 has shown best-in-class activity in reducing HBsAg across multiple preclinical models.” said Dr. Guofeng Cheng, CEO and co-founder of AusperBio, “Over 250 million people are infected with HBV globally and CHB is a difficult to cure viral infection disease that can lead to liver cirrhosis and cancer. Current standard of care can suppress HBV replication, but the cure rate is low. There is a great need to develop safe and finite therapies for HBV cure. AHB-137 has the potential to transform the treatment of CHB patients.”
“The completion of the first cohort dosing of AHB-137 is a significant achievement for AusperBio.” said Dr. Chris Yang, CSO and co-founder of AusperBio, “We are proud of the progress AusperBio has made over the past three years. We are looking forward to advancing additional HBV cure candidates into clinic studies in 2023 for combination therapies and leveraging the potential of our proprietary and potent ASO platform to expand into non-viral targets in and outside the liver.”
The Phase 1 clinical trial is a randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics of AHB-137 in healthy volunteers and initial efficacy in CHB patients (clinicaltrials.gov # NCT05717686). AHB-137 can trigger the degradation of all HBV RNA and has demonstrated potent reduction of HBsAg with favorable safety profile in preclinical studies. The detailed preclinical profiles of AHB-137 have been submitted for two presentations at an upcoming scientific congress in June.
AusperBio is a clinical-stage biopharmaceutical company with operations in China and the USA, dedicated to the development of innovative, best-in-class therapeutics for curing HBV infections. The company’s mission is to become a world leader in antiviral therapeutics. The company has developed a proprietary ASO technology platform, which enables effective and potent targeted therapies for liver diseases, with the potential for expansion into new target areas beyond the liver. AusperBio’s strategy is to combine its leading oligonucleotide therapies with therapeutic antibodies and mRNA vaccines to address a broad range of unmet medical needs.