Huahui Health Launches Novel Libevitug (HH-003) for Treatment of Chronic Hepatitis D Virus Infection

Huahui Health has introduced a novel investigational drug candidate, Libevitug (HH-003), aimed at treating chronic hepatitis D virus (HDV) infection. This anti-PreS1 human monoclonal antibody is designed to target and neutralise both hepatitis B virus (HBV) and HDV.

The results of the HH003-201 study were presented at the European Association for the Study of the Liver (EASL) 2023 Annual Meeting. The HH003-204 study is still ongoing, with final results expected upon its completion.

Libevitug works by specifically targeting the pre-S1 domain of the viral large envelope protein, preventing the HBV and HDV viruses from binding to their receptor, NTCP, and entering hepatocytes, thus neutralising the infections.

HDV, an RNA virus that targets the liver, relies on HBV for replication. The virus infects liver cells through the NTCP receptor. Chronic HDV infections are always accompanied by HBV infections, and this co-infection is known to cause the most severe form of viral hepatitis, often progressing rapidly to cirrhosis and hepatocellular carcinoma.

US FDA has granted breakthrough therapy designation for the treatment of patients with chronic hepatitis delta virus (HDV) infection.