FDA Designates Huahui Health's Libevitug (HH-003) as Breakthrough Therapy for Chronic Hepatitis D

Huahui Health, a clinical-stage biotechnology firm dedicated to discovering and developing innovative treatments for viral hepatitis, hepatology, and oncology, has announced a significant milestone for its hepatitis D and B drug candidate, Libevitug (HH-003). This investigational drug, designed as an anti-PreS1 human monoclonal antibody, has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of chronic hepatitis delta virus (HDV) infection.

The BTD decision is based on promising data from two separate clinical trials involving patients with chronic HDV infection: HH003-201 (NCT05674448) and HH003-204 (NCT05861674). Findings from the HH003-201 trial were presented at the European Association of Liver Diseases 2023 Annual Meeting. The HH003-204 trial is still ongoing, with Huahui Health planning to share the final results upon its conclusion.

The FDA's BTD aims to facilitate the development and review of drugs intended to treat serious or life-threatening conditions. For Libevitug, this designation means it can access the benefits associated with Fast Track designation, including guidance from the FDA on efficient drug development and a quicker regulatory review process in the U.S. This ultimately aims to accelerate the drug's development and increase its availability to chronic HDV patients globally.

Dr. Bin Chen, CEO of Huahui Health, expressed his enthusiasm, stating, "Libevitug received BTD from the China NMPA (National Medical Products Administration) in April 2023 for chronic HDV treatment. The FDA's recent BTD is a significant advancement in Libevitug's clinical development. We are committed to delivering this new therapeutic option to HDV patients worldwide as soon as possible."

Chronic HDV infection, caused by an RNA virus that relies on Hepatitis B Virus (HBV) for replication, presents serious health risks. HDV requires HBV for assembly and infects liver cells via the receptor sodium taurocholate co-transporting polypeptide (NTCP). Chronic HDV infection often coexists with HBV infection, and this co-infection is considered the most severe form of viral hepatitis due to its rapid progression to cirrhosis and hepatocellular carcinoma. The World Health Organization (WHO) estimates that 15 to 20 million people worldwide are chronically infected with HDV. The WHO's 2024 guidelines for managing chronic hepatitis B infection recommend testing for HDV in individuals who are hepatitis B surface antigen (HBsAg) positive, where feasible. Currently, no approved treatments for chronic HDV infection exist in China or the U.S.

Libevitug (HH-003) is a groundbreaking anti-HBV/HDV neutralizing antibody targeting the pre-S1 domain of the viral large envelope protein. By blocking the binding of HBV and HDV to their receptor NTCP, Libevitug prevents the viruses from entering liver cells and neutralizes the infection.

Huahui Health Ltd. (HHHbio), founded in 2015, is committed to developing novel therapies for liver diseases and oncology, focusing on chronic hepatitis B and D, two of the most widespread and devastating infectious diseases globally. Leveraging extensive expertise in disease biology and protein engineering, the company has expanded its pipeline to include multiple first- and best-in-class candidates.

Huahui Health operates under core values of Innovation, Truth-Seeking, and Collaboration, aiming to become a globally respected leader in biopharmaceuticals.