HH-003 / Huahui Health - LARVOL DELTA

A Study to Assess Efficacy and Safety of HH-003 Injection in Subjects With Chronic Hepatitis Delta Virus Infection (clinicaltrials.gov) - P2 | N=101 | Completed | Sponsor: Huahui Health | Enrolling by invitation ➔ Completed

Trial completion • Infectious Disease • Inflammation

Hope on the horizon: Emerging therapies for hepatitis D. (PubMed, World J Hepatol) - "Pegylated interferon lambda acts on interferon-lambda (Type III) receptors predominantly expressed in hepatocytes. In 2023, bulevirtide was approved in the European Union and Russia for treating chronic hepatitis D. This drug works by binding to and inhibiting the sodium taurocholate co-transporting polypeptide receptor on liver cells, which is the primary entry point for the virus...Two more viral entry inhibitors are HH003 and tobevibart. Other agents include nucleic acid polymers (REP 2139-Mg), prenylation inhibitors (lonafarnib), and RNA interference-based therapies (elebsiran)...The efficacy and safety of these drugs will further be evaluated in ECLIPSE 1, 2, and 3 trials. With these new treatments on the horizon, the prospects for improved HDV patient outcomes are promising."

Journal • Review • Hepatitis B • Infectious Disease • Inflammation • IFNA1

Blocking HDV/HBV Entry Through NTCP for Curative Therapy: Opportunities and Challenges (APASL 2025) - "Clinical trials of Libevitug have shown good safety profile across various patient groups infected by HBV and /or HDV, and monotherapy of HH-003 exhibits promising antiviral activity in chronic hepatitis B patients and particularly in patients coinfected by HDV. The therapeutic efficacy of Libevitug and other entry inhibitors is yet to be more thoroughly assessed in combination - based treatments for the purpose of achieving curative therapies."

Hepatitis B • Hepatology • Inflammation

A Study to Evaluate the Antiviral Activity and Safety of HH-003 in Chronic Hepatitis B Subjects With Low-level Viremia (clinicaltrials.gov) - P2 | N=74 | Completed | Sponsor: Huahui Health | Active, not recruiting ➔ Completed | Phase classification: P2a ➔ P2 | Trial primary completion date: Apr 2023 ➔ Apr 2024

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

A Study to Assess Efficacy and Safety of HH-003 Injection in Subjects With Chronic Hepatitis Delta Virus Infection (clinicaltrials.gov) - P2 | N=80 | Enrolling by invitation | Sponsor: Huahui Health | Recruiting ➔ Enrolling by invitation | Phase classification: P2b ➔ P2

Enrollment status • Phase classification • Hepatology • Infectious Disease • Inflammation

A Study to Assess Efficacy and Safety of HH-003 Injection in Subjects With Chronic Hepatitis Delta Virus Infection (clinicaltrials.gov) - P2b | N=80 | Recruiting | Sponsor: Huahui Health | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology • Infectious Disease • Inflammation

A Study to Evaluate the Antiviral Activity and Safety of HH-003 in Chronic Hepatitis B Subjects With Low-level Viremia (clinicaltrials.gov) - P2a | N=75 | Active, not recruiting | Sponsor: Huahui Health | Recruiting ➔ Active, not recruiting

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

A Study to Evaluate the Antiviral Activity and Safety of HH-003 Injection in Subjects With Chronic Hepatitis B and Hepatitis D Co-infection (clinicaltrials.gov) - P2a | N=9 | Terminated | Sponsor: Huahui Health | Active, not recruiting ➔ Terminated; During the study, the sponsor adjusted the overall clinical development strategy, decided to terminate the enrollmentin advance after discussion with the lead investigator.

Trial termination • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study to Evaluate the Antiviral Activity and Safety of HH-003 Injection in Subjects With HBeAg-Negative Chronic Hepatitis B Treated With Nucleos(t)Ide Reverse Transcriptase Inhibitors (clinicaltrials.gov) - P2a | N=73 | Completed | Sponsor: Huahui Health | Active, not recruiting ➔ Completed

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

Safety and efficacy of anti-pre-S1 domain monoclonal antibody (HH-003) treatment in patients with co-infection of chronic hepatitis B virus (HBV) and hepatitis D virus (HDV): a single center, open-label, phase 2 trial (EASL-ILC 2023) - P2a | "HH-003 treatment at a dose of 20 mg/kg demonstrated significant decrease of HDV RNA level and ALT normalization, with a good safety profile in participants co-infected with HBV and HDV. HH-003 might provide a new treatment option for patients with HBV and HDV co-infection, and a large-scale study will be conducted to further demonstrate such a promising anti-viral effect of HH-003 in patients with HBV and HDV co-infection. Figure: Efficacy outcomes from the study."

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

A Study to Assess Efficacy and Safety of HH-003 Injection in Subjects With Chronic Hepatitis Delta Virus Infection (clinicaltrials.gov) - P2b | N=80 | Not yet recruiting | Sponsor: Huahui Health

New P2b trial • Hepatology • Infectious Disease • Inflammation

A Study to Evaluate the Antiviral Activity and Safety of HH-003 Injection in Subjects With HBeAg-Negative Chronic Hepatitis B Treated With Nucleos(t)Ide Reverse Transcriptase Inhibitors (clinicaltrials.gov) - P2a | N=73 | Active, not recruiting | Sponsor: Huahui Health

New P2a trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study to Evaluate the Antiviral Activity and Safety of HH-003 in Chronic Hepatitis B Subjects With Low-level Viremia (clinicaltrials.gov) - P2a | N=75 | Recruiting | Sponsor: Huahui Health

New P2a trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study to Evaluate the Antiviral Activity and Safety of HH-003 Injection in Subjects With Chronic Hepatitis B and Hepatitis D Co-infection (clinicaltrials.gov) - P2a | N=9 | Active, not recruiting | Sponsor: Huahui Health

New P2a trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A FIRST-IN-PATIENT PHASE IB STUDY OF A HEPATITIS B VIRUS (HBV) NEUTRALIZING ANTIBODY HH-003 IN TREATMENT NAà VE PARTICIPANTS WITH HBEAG-POSITIVE CHRONIC HBV INFECTION (AASLD 2022) - "HH-003 was safe and well-tolerated, and demonstrated a dose-dependent PK profile in the treatment naïve, HBeAg-positive CHB participants. Three doses of 20 mg/kg of HH-003 resulted in optimum dose exposure and antiviral activity in immune active participants."

Clinical • Late-breaking abstract • P1 data • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation

A Study to Evaluate the Safety, Tolerability of HH-003 Injection in Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - P1 | N=68 | Completed | Sponsor: Huahui Health

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