AHB-137 / Ausper Biopharma - LARVOL DELTA

Study to Evaluate the Efficacy and Safety of AHB-137 in Treatment-naive Participants With Chronic Hepatitis B (CHB) (clinicaltrials.gov) - P2 | N=124 | Recruiting | Sponsor: Ausper Biopharma Co., Ltd. | N=60 ➔ 124

Enrollment change • Hepatitis B • Infectious Disease • Inflammation

Long-term Follow-up Study to Evaluate Participants With Chronic Hepatitis B (CHB) Previously Treated With AHB-137 Injection (clinicaltrials.gov) - P=N/A | N=200 | Not yet recruiting | Sponsor: Ausper Biopharma Co., Ltd.

New trial • Hepatitis B • Infectious Disease • Inflammation

A Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB) (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Ausper Biopharma Co., Ltd.

New P2 trial • Hepatitis B • Infectious Disease • Inflammation

A Multicenter Study of AHB-137 Injection Combined With Other Hepatitis B Drugs (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Ausper Biopharma Co., Ltd.

New P2 trial • Hepatitis B • Infectious Disease • Inflammation

AusperBio Receives China CDE Clearance to Advance AHB-137 into Phase III Clinical Trial for Chronic Hepatitis B (Newswise) - "AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd...announced that the China Center for Drug Evaluation (CDE) has approved the initiation of a Phase III clinical trial for its lead candidate, AHB-137...The Phase III trial is a randomized, double-blind, multicenter study in China evaluating the efficacy and safety of 24-week treatment with AHB-137 (300 mg) in HBeAg-negative CHB patients who are receiving stable nucleos(t)ide analogue therapy."

New P3 trial • Hepatitis B

A Study to Evaluate the Antiviral Activity and Immune Response of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB) (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Ausper Biopharma Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatitis B • Infectious Disease • Inflammation

A Study to Evaluate the Antiviral Activity and Immune Response of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB) (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Ausper Biopharma Co., Ltd.

New P2 trial • Hepatitis B • Infectious Disease • Inflammation

HBsAg loss and seroconversion after 16-week or 24-week AHB-137 treatment in HBeAg-negative chronic hepatitis B participants on NA therapy: results from an ongoing multicenter, randomized phase IIb study (EASL 2025) - P2 | "In this ongoing Phase IIb trial, high rates of HBsAg loss and seroconversion have been achieved following either 16 or 24 weeks of treatment with 300 mg AHB-137. Both regimens demon- strated favourable safety and tolerability profiles. These efficacy and safety results are consistent with the observations from the previous Phase IIa study, further supporting AHB-137 development for HBV functional cure."

Clinical • Late-breaking abstract • P2b data • Dermatology • Hepatitis B • Hepatitis C • Hepatology • Infectious Disease • Inflammation

Next generation hepatitis B virus antisense oligonucleotides incorporating novel chemistries demonstrated significantly improved properties compared to current clinical candidates (EASL 2025) - "Background and Aims: Chronic hepatitis B (CHB) patients can achieve functional cure after monotherapy with antisense oligonucleotides (ASO) targeting hepatitis B virus (HBV) RNA, e.g. GSK- 836 and AHB-137... Applying novel chemistries could improve RNase H-mediated, hTLR8 and Caspase 3/7 profiles of HBV ASOs. Among several lead ASOs, ALG-170961 exhibited the most significantly improved in vivo efficacy when compared with current clinical stage compounds."

Clinical • Hepatitis B • Hepatitis C • Hepatology • Infectious Disease • Inflammation • CASP3 • CASP7 • TLR8

Robust HBsAg Loss after AHB-137 Treatment in HBeAg-Negative Chronic Hepatitis B Patients on NA Therapy: 24-Week ON Treatment and 8-Week OFF Treatment Results from an Ongoing Multicenter, Randomized, Open-Label Phase IIa Study (APASL 2025) - P1/2 | "In this ongoing phase IIa trial, AHB-137 treatment was well tolerated and led to rapid HBsAg reduction and loss. In the 300 mg arm, the rate of virologic response was 63% (20/32) at the end of AHB-137 treatment and 59% (10/17) at 8 weeks of the OFF AHB-137 treatment phase. Current data support further development of AHB-137 for HBV functional cure."

Clinical • Late-breaking abstract • P2a data • Dermatology • Hepatitis B • Hepatitis C • Hepatology • Infectious Disease • Inflammation

Study to Evaluate the Efficacy and Safety of AHB-137 in Treatment-naive Participants with CHB with Low Viral Load (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Ausper Biopharma Co., Ltd.

New P2 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study Evaluating AHB-137 in Healthy Participants and Participants with Chronic Hepatitis B (clinicaltrials.gov) - P1 | N=64 | Completed | Sponsor: AusperBio Therapeutics Inc. | Active, not recruiting ➔ Completed | Trial primary completion date: Aug 2024 ➔ Jan 2025

Trial completion • Trial primary completion date • Hepatitis B • Hepatology • Infectious Disease • Inflammation

AusperBio Reaches Key Milestone with Dosing Completion and Study Unblinding in Ongoing AHB-137 Phase IIb Trial (PRNewswire) - "AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd...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."

Trial status • Hepatitis B

AusperBio Secures $73 Million in Series B Financing to Advance Functional Cure for Chronic Hepatitis B (PRNewswire) - "AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. (collectively AusperBio)...announced the successful completion of a USD 73 million Series B financing....The proceeds will fund the continued Phase 2 development of AHB-137, AusperBio's lead investigational therapy, supporting both clinical studies in China and global trials, as well as the development of commercial-scale manufacturing processes. The funding will also facilitate the expansion of the company's therapeutic pipeline and operational capabilities to drive sustained growth."

Financing • Hepatitis B

A Study to Evaluate the Safety and Efficacy of AHB-137 in Healthy Participants and HBeAg-negative Chronic Hepatitis B (CHB) Patients (clinicaltrials.gov) - P1/2 | N=270 | Active, not recruiting | Sponsor: Ausper Biopharma Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Subjects With Chronic Hepatitis B (CHB). (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: Ausper Biopharma Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study to Evaluate the Safety and Efficacy of AHB-137 in Healthy Participants and HBeAg-negative Chronic Hepatitis B (CHB) Patients (clinicaltrials.gov) - P1/2 | N=270 | Recruiting | Sponsor: Ausper Biopharma Co., Ltd. | Phase classification: P1 ➔ P1/2 | Trial completion date: Oct 2024 ➔ Jan 2026 | Trial primary completion date: Apr 2024 ➔ Dec 2024

Phase classification • Trial completion date • Trial primary completion date • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Subjects With Chronic Hepatitis B (CHB). (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Ausper Biopharma Co., Ltd.

New P2 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A phase 1, dose‑escalation and dose‑expansion study evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of AHB-137 in Chinese healthy volunteers and subjects with chronic hepatitis B (EASL-ILC 2024) - "AHB-137 administrated subcutaneously as SAD up to 450 mg and MAD up to 300 mg was safe and well tolerated in both HVs and CHB subjects. Overall, AHB-137 was well tolerated, had favourable PK profile, and promising efficacy results, supporting the further development of AHB-137 as a candidate for functional cure of CHB."

Clinical • Late-breaking abstract • P1 data • PK/PD data • Hepatitis B • Hepatology • Infectious Disease • Inflammation • CRP

Safety and antiviral activity of AHB-137, a novel antisense oligonucleotide, in healthy volunteers and subjects with chronic hepatitis B (EASL-ILC 2024) - "Single doses of AHB-137 up to 450 mg and multiple doses up to 300 mg for 4 weeks were safe and well tolerated in HVs and CHB subjects. Over 2 log10 IU/mL HBsAg reduction was achieved in > 30% CHB subjects with baseline HBsAg < 10,000 IU/mL and could led to sustained HBsAg loss with a 4-week AHB-137 treatment at 300 mg. AHB-137 monotherapy with background NA treatment demonstrated promising potential for achieving a functional cure of CHB."

Clinical • Late-breaking abstract • Dermatology • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Musculoskeletal Pain • Pain

A Study Evaluating AHB-137 in Healthy Participants and Participants With Chronic Hepatitis B (clinicaltrials.gov) - P1 | N=90 | Active, not recruiting | Sponsor: AusperBio Therapeutics Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study to Evaluate the Safety and Efficacy of AHB-137 in Healthy Participants and Chronic Hepatitis B Patients (clinicaltrials.gov) - P1 | N=270 | Recruiting | Sponsor: Ausper Biopharma Co., Ltd.

New P1 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study Evaluating AHB-137 in Healthy Participants and Participants With Chronic Hepatitis B (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: AusperBio Therapeutics Inc. | N=60 ➔ 90

Enrollment change • Hepatitis B • Hepatology • Infectious Disease • Inflammation

AusperBio Announces FDA Clearance of IND Application of AHB-137 in Chronic Hepatitis B Treatment (PRNewswire) - "AusperBio Therapeutics, Inc. and Ausper Biopharma....today announced the U.S. Food and Drug Administration (FDA) has granted clearance for the Investigational New Drug (IND) application for a clinical trial on AHB-137. The clinical trial in the US is part of a multiregional, randomized, double-blinded, placebo-controlled study, intended to assess the safety, tolerability, pharmacokinetics, and initial efficacy of AHB-137 in CHB patients (clinicaltrials.gov # NCT05717686)."

IND • Hepatitis B • Infectious Disease

AusperBio Announces IND Approval from China CDE for HBV ASO AHB-137 (PRNewswire) - "AusperBio Therapeutic, Inc. and Ausper Biopharma Co., Ltd. (Together AusperBio)...announced that the Center for Drug Evaluation (CDE) of China has approved the Investigational New Drug (IND) application of AHB-137 to treat chronic hepatitis B (CHB) aiming for functional cure....The approved clinical trial protocol (CXHL2300362) is a randomized, double-blind, placebo-controlled phase I study to evaluate the safety, tolerability, pharmacokinetics, and initial antiviral activity of AHB-137 with single ascending doses and multiple ascending doses in healthy volunteers and chronic Hepatitis B Patients."

New P1 trial • Hepatitis B • Infectious Disease