AHB-137 / AusperBio - LARVOL DELTA

Phase II clinical trial evaluating the use of AHB-137 for the treatment-naïve participants with chronic hepatitis B (ChiCTR) - P2 | N=320 | Not yet recruiting | Sponsor: The 2nd Affiliated Hospital of Chongqing Medical University; The 2nd Affiliated Hospital of Chongqing Medical University

New P2 trial • Hepatitis B • Infectious Disease • Inflammation

Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB). (clinicaltrials.gov) - P2 | N=86 | Completed | Sponsor: Ausper Biopharma Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Oct 2026 ➔ Jan 2026

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

AusperBio Completes $120 Million Series C Financing to Advance AHB-137 Toward Potential Commercialization and Expand Next-Generation HBV Therapies (PRNewswire) - "The financing will support the continued development of AHB-137, AusperBio's lead investigational ASO therapy for CHB, including its Phase 3 registrational program and commercialization readiness."

Financing • Hepatitis B • Infectious Disease

A First-in-Human study of AHB-137, an unconjugated antisense oligonucleotide, in healthy subjects and patients with chronic hepatitis B. (PubMed, Hepatology) - "In this Phase 1 study, AHB-137 demonstrated an acceptable safety profile, predictable PK, and rapid and prolonged HBsAg reductions, supporting further evaluation of dosing and treatment duration in CHB."

First-in-human • Journal • P1 data • Hepatitis B • Infectious Disease • Inflammation • Pain

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=20 | Active, not recruiting | Sponsor: Ausper Biopharma Co., Ltd. | Trial completion date: Feb 2027 ➔ Nov 2027 | Trial primary completion date: Jul 2026 ➔ Jul 2027

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

ASPIRE-202: Study of AHB-137 in Chronic Hepatitis B (CHB) Participants in North America and Europe Regions (clinicaltrials.gov) - P2 | N=70 | Recruiting | Sponsor: AusperBio Therapeutics Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • 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=200 | Recruiting | Sponsor: Ausper Biopharma Co., Ltd. | N=60 ➔ 200

Enrollment change • Hepatitis B • Infectious Disease • Inflammation

A Study to Evaluate AHB-137 Injection in Treatment-nave Participants With Chronic Hepatitis B (clinicaltrials.gov) - P2 | N=320 | Recruiting | Sponsor: Ausper Biopharma Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatitis B • Infectious Disease • Inflammation

A Clinical Study Evaluating the Pharmacokinetic Characteristics and Safety of AHB-137 Injection in Participants With Mild to Moderate Liver Dysfunction and Those With Normal Liver Function. (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Ausper Biopharma Co., Ltd. | Not yet recruiting ➔ Recruiting

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

ASPIRE-202: Study of AHB-137 in Chronic Hepatitis B (CHB) Participants in North America and Europe Regions (clinicaltrials.gov) - P2 | N=70 | Not yet recruiting | Sponsor: AusperBio Therapeutics Inc.

New P2 trial • Hepatitis B • Infectious Disease • Inflammation

A Study to Evaluate AHB-137 Injection in Treatment-naïve Participants With Chronic Hepatitis B (clinicaltrials.gov) - P2 | N=320 | Not yet recruiting | Sponsor: Ausper Biopharma Co., Ltd.

New P2 trial • Hepatitis B • Infectious Disease • Inflammation

AHB-137 monotherapy elicits high functional cure rates and sustained DNA suppression in treatment-naïve chronic hepatitis B participants: results from an ongoing phase II study (EASL 2026) - P2 | "In treatment-naive CHB participants, AHB-137 monotherapy demonstrated potent inhibition of HBV DNA replication and profound reduction of HBsAg, resulting in a high FC rate. Overall, AHB-137 was generally well-tolerated, coupled with durable off-treatment HBV DNA suppression. These data support the further development of AHB-137 in a broader CHB population."

Late-breaking abstract • Monotherapy • P2 data • Hepatitis B • Hepatitis C • Hepatology • Infectious Disease • Inflammation

Sequential combination of antisense oligonucleotide AHB-137 followed by HBV vaccine leads to HBsAg loss and seroconversion in the AAV-HBV mice (EASL 2026) - "Sequential combination of AHB-137 with HBV vaccine in the AAV-HBV mice effectively sustain serum HBsAg loss by concomitantly activating HBsAg-specific B cells to produce high-titer neutralizing HBsAb. This result demonstrated a potential combination therapy strategy for achieving higher functional cure rate in CHB patients."

Preclinical • Hepatitis B

The potentially best-in-class HBV ASO ALG-170674 demonstrates additive to synergistic antiviral activities when combined with other anti-HBV modalities (EASL 2026) - "Background and aims: Chronic hepatitis B (CHB) patients can achieve a modest rate of functional cure after monotherapy with antisense oligonucleotides (ASO) e.g. bepirovirsen (GSK-836) and AHB-137. ALG-170674 exhibited potential to be a best-in-class HBV ASO. Additive to synergistic effects were observed when combining ALG-170674 and ALG-001075 (or close analogs) in preclinical studies. Combination of ALG-170674 and ALG-000184 could potentially improve functional cure rates in CHB patients, particularly in patients with higher baseline levels of HBsAg."

Hepatitis B • Hepatitis C • Hepatology • Inflammation • IL6 • TLR8

Safety, pharmacokinetics and antiviral activity of AHB‑137 in healthy volunteers and chronic hepatitis B patients: a phase 1a/1b study. (PubMed, Hepatol Int) - P1/2 | "AHB-137 demonstrated favorable safety, predictable PK, and dose-dependent HBsAg reductions, including HBsAg loss, supporting its further development for CHB functional cure."

Journal • P1 data • PK/PD data • Hepatitis B • Infectious Disease • Inflammation

A Clinical Study Evaluating the Pharmacokinetic Characteristics and Safety of AHB-137 Injection in Participants With Mild to Moderate Liver Dysfunction and Those With Normal Liver Function. (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Ausper Biopharma Co., Ltd.

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

A Multicenter Study of AHB-137 Injection Combined With Other Hepatitis B Drugs (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Ausper Biopharma Co., Ltd. | Active, not recruiting ➔ Recruiting | N=127 ➔ 200 | Trial completion date: May 2027 ➔ Jan 2028 | Trial primary completion date: Jan 2027 ➔ Jul 2027

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Hepatitis B • Infectious Disease • Inflammation

Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB). (clinicaltrials.gov) - P2 | N=86 | Active, not recruiting | Sponsor: Ausper Biopharma Co., Ltd. | Trial completion date: Jun 2026 ➔ Oct 2026 | Trial primary completion date: Feb 2026 ➔ May 2025

Trial completion date • Trial primary completion date • Hepatitis B • 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=129 | Completed | Sponsor: Ausper Biopharma Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Hepatitis B • Infectious Disease • Inflammation

Study to Evaluate the Efficacy and Safety of AHB-137 in Treatment-naive Participants With Chronic Hepatitis B (CHB) (clinicaltrials.gov) - P2 | N=105 | Active, not recruiting | Sponsor: Ausper Biopharma Co., Ltd. | Trial completion date: Nov 2025 ➔ Dec 2026 | Trial primary completion date: Oct 2025 ➔ Aug 2026

Trial completion date • Trial primary completion date • 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 | Recruiting | Sponsor: Ausper Biopharma Co., Ltd. | Not yet recruiting ➔ Recruiting | Trial primary completion date: Jan 2026 ➔ Dec 2026

Enrollment open • Trial primary completion date • 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 | 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=20 | Active, not recruiting | Sponsor: Ausper Biopharma Co., Ltd. | Recruiting ➔ Active, not recruiting | N=30 ➔ 20

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

ASPIRE: Phase 2 Study of AHB-137 in HBeAg Negative Chronic Hepatitis B (CHB) Participants in Asia Pacific Region (clinicaltrials.gov) - P2 | N=84 | Recruiting | Sponsor: AusperBio Therapeutics Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatitis B • Infectious Disease • Inflammation

ASPIRE: Phase 2 Study of AHB-137 in HBeAg Negative Chronic Hepatitis B (CHB) Participants in Asia Pacific Region (clinicaltrials.gov) - P2 | N=84 | Not yet recruiting | Sponsor: AusperBio Therapeutics Inc.

New P2 trial • Hepatitis B • Infectious Disease • Inflammation