Huahui Health, a clinical-stage biotechnology company focused on discovering and developing novel therapies in the areas of viral hepatitis, hepatology, and oncology, today announced that its investigational hepatitis D and B drug candidate, Libevitug (HH-003), an anti-PreS1 human monoclonal antibody, received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for the treatment of patients with chronic hepatitis delta virus (HDV) infection.

The BTD is based on the clinical results from two independent clinical trials in subjects with chronic HDV infection, HH003-201 (NCT05674448) and HH003-204 (NCT05861674). The result of HH003-201 study has been presented at the European Association of Liver Diseases 2023 Annual Meeting. The HH003-204 study remains ongoing, and Huahui Health will publish the final results when it is completed.

The FDA BTD is designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening disease or condition. The BTD grant for Libevitug enables it to benefit from all Fast Track designation features, including FDA's guidance on efficient drug development and expedited regulatory review in the U.S., and ultimately can accelerate its development and enhance accessibility for chronic HDV infected patients worldwide.

"Libevitug received BTD from the China NMPA (National Medical Products Administration) in April 2023 for the treatment of chronic HDV infection. Today's FDA BTD further signifies a remarkable step forward in the clinical development of Libevitug. We are fully committed to bringing this new therapeutic option to HDV patients worldwide the soonest we can." commented Dr. Bin Chen, CEO of Huahui Health.