AusperBio Announces Major Progress in AHB-137 Clinical Development

• A total of 122 participants, including 30 CHB patients, have received administration of AHB-137
• Enrollment of CHB patients in the 150mg and 300mg cohorts has been completed in China
• Six CHB patients have completed 4-week dosing in the study in the US and New Zealand
• Chronic tox studies in monkeys have completed the in-life phase and histopathological evaluation.

SAN FRANCISCO, Feb. 14, 2024 /PRNewswire/ -- AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. (Together AusperBio), a clinical-stage biotechnology company dedicated to advancing oligonucleotide therapies, with a primary focus on achieving a functional cure for chronic hepatitis B (CHB) infection, today announced significant updates on the clinical development of its leading molecule, AHB-137, an unconjugated antisense oligonucleotide (ASO) targeting all HBV RNA.

AHB-137, empowered by AusperBio's proprietary Med-Oligo^TM ASO technology platform, holds the potential as a backbone in the quest for a functional cure for CHB. This novel dual-mechanism ASO has been evaluated in two Phase 1a/1b clinical trials in parallel, one in China and another outside China. To date, 122 participants, including 30 CHB patients, have received either single or multiple doses of AHB-137. In China (chinadrugtrials.org.cn #CTR20232098; clinicaltrials.gov #NCT06115993), enrollment of CHB patients in the 150mg and 300mg cohorts has been completed. The study outside China (clinicaltrials.gov #NCT05717686) is also rapidly progressing in dosing of CHB patients, with 6 participants having completed 4-week dosing in the US and New Zealand.

"The rapid progress of AHB-137's clinical development across multiple regions is truly remarkable. This milestone signifies another crucial turning point for AusperBio, and I am extremely proud of our team's consistent and outstanding execution in advancing innovative therapies toward a functional cure for CHB," said Dr. Guofeng Cheng, AusperBio CEO and co-founder. "This achievement owes gratitude to our study principal investigators, participants, clinical CROs, and many others who have gone above and beyond to accelerate the clinical development of AHB-137."

"What we have accomplished for AHB-137 in less than a year since the first dosing in human is incredibly exciting. We are very encouraged by the initial efficacy data observed in CHB patients. Importantly, having this large safety dataset in such a short timeframe instills greater confidence for the continued development of AHB-137." Commented Dr. Chris Yang, co-founder and CSO. "Following the successful completion of the 26-week chronic tox studies in monkeys and mice, we are poised to swiftly progress AHB-137 into Phase II clinical studies. We eagerly look forward to presenting the results of our clinical studies at the upcoming international conferences."

About Chronic Hepatitis B

Chronic Hepatitis B (CHB) infection is a liver disease estimated to affect nearly 290 million people worldwide and is a leading cause of major liver diseases such as liver cirrhosis and hepatocellular carcinoma. Although current treatment options can suppress HBV replication, achieving a cure is rare. Therefore, the discovery of a cure for CHB with finite treatment is a serious and urgent medical need.

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^TM 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-Oligos^TM Platform empowers ASO therapeutics to treat a broad range of diseases, including viral infections, metabolic conditions, genetic disorders, and immune diseases.

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SOURCE AusperBio Therapeutics Inc.