AusperBio Announces 30% Functional Cure Rate with AHB-137 Monotherapy in Chronic Hepatitis B Patients in Phase IIa Trial

12Month12Day,AusperBio (AusperBio) InHEP-DART 2025 Frontier ConferenceAbove, its core product was announced in the form of an oral report. AHB-137 The IIa Phase Clinical Trial (AB-10-8002) ofFollow-up ended (End of Follow-up, EOF) Data。

Data show that, at baselineHBsAgFor100-1,000 IU/mLAmong the patients, for a period of24Week'sAHB-137Monotherapy on Day72Week (EOF) Reach30%The clinical cure rate. This breakthrough data further demonstrates AHB-137 The potential to become a cornerstone drug for hepatitis B cure.

72Weekly Follow-up (EOF) Main findings:

• Significantly Effective Monotherapy

At baselineHBsAgFor100-1,000 IU/mLAmong the patients,30%The subject achieved clinical cure (HBsAg <0.05 IU/mL And HBV DNA< LLOQ), and in225 mgAnd300 mgThe results were consistent in both dose groups. For the baselineHBsAgHigher (1,00–3,000 IU/mL) patients,AHB-137The clinical cure rate is13%（225 mg) and19%（300 mg）。

•AllPersistent Viral Replication Suppression After Discontinuation of Treatment

CompletedAHB-137After treatment and discontinuation of nucleos(t)ide analogs,100%Patients in24Maintain within the weekHBV DNANegative, showingAHB-137The treatment has a lasting effect on suppressing viral replication.

• Durable complete response after discontinuation of all medications

CompletedAHB-137After treatment and discontinuation of nucleos(t)ide analogs, At baseline100-1,000 IU/mL And100-3,000 IU/mL In the patients, the combined analysis of the two doses respectively had 89% And 82% Subjects maintained a complete response (HBsAg <0.05 IU/mL And HBV DNA, showing AHB-137 Complete response acquired from treatment NA Good persistence after discontinuation of the drug.

•Good Safety and Tolerability

AHB-137The treatment was well-tolerated during the treatment and follow-up periods, with no serious drug-related adverse events reported and no treatment interruptions. Most adverse events were mild to moderate and occurred during the dosing phase.

Principal Investigator of This Study, Professor Junqi Niu from the First Hospital of Jilin UniversityRepresentation："Near20Over the years, tremendous progress has been made in the treatment of viral hepatitis B,But achieving a functional cure remains very difficult. In the research consensus among China, the U.S., and Europe, approximately 30% The functional cure rate is widely regarded as a key milestone for curative therapies achieving significant breakthroughs. As of now, AusperBio AHB-137 Is the world's first single-drug treatment to achieve this breakthrough in the main target population of hepatitis B patients. In addition to reducing hepatitis B surface antigen and viral load,DNAClinically cured patients who have turned negative, and many other patients who have not yet turned negative also have very low levels of surface antigen, becoming candidates for follow-up treatment or combination therapy.‘Target Population’。This progress is expected to change our past‘Control Rather Than Cure’The current state of treatment can achieve a cure in a short period of time, significantly reducing the risk of liver cirrhosis and liver cancer, which has important clinical value. The dawn of people being free from the troubles of hepatitis B has appeared."

Famous Hepatologist and Deputy Director of the New Zealand Liver Center at Auckland City Hospital Edward J. Gane ProfessorStated: "After a short-term, limited course of treatment, it is possible to continuously clear hepatitis B surface antigens from circulation.HBV DNA, that is, achieving clinical cure, is extremely difficult to realize in patients with chronic hepatitis B. Therefore,AHB-137 The remarkable clinical cure rate achieved with monotherapy in clinical trials is particularly encouraging. Its rapid and profound HBsAg A decline followed by sustained viral control even after discontinuation of the drug, this clinical manifestation of persistent viral suppression is highly consistent with the key biological mechanisms required for a clinical cure.The cure rate observed in this study is when the hepatitis B virus was discovered 60 One of the most important treatment advances in recent years。”

Co-founder andCEODr. Guofeng ChengSaid: "We are very proud to be ableHEP-DARTThis milestone data was shared on a platform that gathers the world's top liver disease experts. The clinical cure rate at the end of the follow-up not only validates AHB-137 Potent antiviral effects have also been preliminarily confirmed throughASOReduce Surface Antigen Expression from the Source, Inhibit the VirusDNAThe cornerstone potential of achieving highly efficient clinical cures through the 'triple mechanism' of replication and immune modulation. We will accelerate the advancement of ongoing pivotal clinical trials, moving towards‘To Help Hepatitis B Patients Achieve Clinical Cure as Soon as Possible’The goal is to sprint with all our might.”

About AB-10-8002 Research

AB-10-8002 Is a multicenter, randomized, open-label II Phase clinical study aimed to evaluate patients receiving stable nucleos(t)ide analog (NA) During treatment,HBeAg Negative chronic hepatitis B (CHB) patients, using AHB-137 Monotherapy 24 Week's Safety and Efficacy. Subjects Receive 24 Week, once a week 300 mg Or 225 mg AHB-137 Treatment (including the 4 Tianhe Day 11 Twice daily loading dose). Completed AHB-137 After treatment, all patients continued to receive NA Treatment 24 Week. Compliance NA The subjects who met the discontinuation criteria were assessed by the investigator on Day 48 Week Stop NA Treatment, and follow-up to the72 Week.

About AHB-137

AHB-137 It is AusperBio (AusperBio) Based on its independently developed Med-Oligo™ A novel non-conjugated antisense oligonucleotide technology platform ASO The drug, currently under investigation as a therapeutic approach, aims to achieve clinical cure for chronic hepatitis B. It features a triple mechanism of action and has demonstrated positive results in both preclinical and clinical trials, with relevant findings already published. EASL（2023-2025）、AASLD（2024-2025) and APASL 2025 Released at international authoritative conferences.AHB-137 Completed globally I Phase clinical trials are currently advancing multiple global initiatives simultaneously. II Phase Clinical Trial and Mainland ChinaIIIPhase clinical trial.

About AusperBio

AusperBioAusperBioIs a clinical-stage innovative drug research and development company operating simultaneously in China and the United States, focusing on the development ofFirst-in-classAndBest-in-classPotential自主创新targeted delivery small nucleic acid drugs. The company owns fully independent intellectual property rights.Med-Oligo™ ASO Technology Platform, Core Focus on Chronic Hepatitis B (HBV) clinical cure and highly efficient targeted treatment for liver diseases, while actively expanding into new target areas beyond the liver. AusperBio's strategy is to leverage globally leadingMed-Oligo™The combination of oligonucleotide technology and specific, efficient targeted delivery platforms drives the development of a series of innovative therapies, thereby addressing significant unmet medical needs.

Disclaimer:

The content of the article is for reference only and does not constitute investment advice. Investors who take action based on this information bear their own risks. The article maintains a neutral stance on the statements and viewpoints presented, and does not provide any express or implied guarantees regarding the accuracy, reliability, or completeness of the content included. Readers are advised to use it solely as a reference and assume full responsibility for their actions.

ABC 2026

Booths are booking up fast!

Scan to consult immediately

Phone: 13816031174

(Same as WeChat)

Sponsorship forms include but are not limited toSpeaking slots, exhibition booths, color pages in the conference proceedings, dinner sponsorship, promotional conference materials, etc.