AHB-137 / Ausper Biopharma - LARVOL DELTA

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) - No abstract available

Clinical • Late-breaking abstract • P2a data • Hepatitis B • 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

AHB-137, a novel hepatitis B virus antisense oligonucleotide with substantially enhanced in vitro and in vivo antiviral activity (EASL-ILC 2023) - "Background and Aims: Antisense oligonucleotide (ASO) bepirovirsen (BPV) monotherapy has demonstrated activity to achieve sustained HBsAg seroclearance in chronic hepatitis B (CHB) patients, with a promise to be a backbone for HBV cure treatment regimen. The AHB-137 represents a novel class of HBV ASO that clearly demonstrated strong antiviral activity against HBV mRNA transcribed from both cccDNA and integrated genomes, and had more potent activity in reducing serum HBsAg than BPV across multiple in vitro and in vivo HBV models. Together with its favorable PK and safety profile, AHB-137 is advancing into clinical development."

Preclinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation

AHB-137, a novel and potent hepatitis B virus antisense oligonucleotide with a favorable preclinical pharmacokinetics and safety profile (EASL-ILC 2023) - "Background and Aims: Antisense oligonucleotide (ASO) bepirovirsen (BPV) monotherapy has demonstrated activity to achieve sustained HBsAg seroclearance in chronic hepatitis B (CHB) patients, with a promise to be a backbone for HBV cure treatment. In addition to potent antiviral activity, the novel HBV ASO AHB-137 has demonstrated a favorable preclinical pharmacokinetics and safety profile. AHB-137 is advancing into clinical development for the treatment of CHB patients."

PK/PD data • Preclinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation

AHB-137, a novel hepatitis B virus antisense oligonucleotide with substantially enhanced in vitro and in vivo antiviral activity (EASL-ILC 2023) - No abstract available

Preclinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study Evaluating AHB-137 in Healthy Participants and Participants With Chronic Hepatitis B (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Ausper Biopharma Co., Ltd. | Not yet recruiting ➔ Recruiting

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

A Study Evaluating AHB-137 in Healthy Participants and Participants With Chronic Hepatitis B (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Ausper Biopharma Co., Ltd.

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