Enochian BioSciences Announces FDA Acceptance of Pre-IND Request For Potential Cure for Hepatitis B Virus Infection
July 12, 2021 at 07:00 AM EDT
LOS ANGELES, July 12, 2021 (GLOBE NEWSWIRE) -- (NASDAQ: ENOB) – Enochian BioSciences, Inc., a company focused on gene-modified cellular and immune therapies in infectious diseases and cancer, today announced that the FDA has accepted a Pre-IND (Investigational New Drug) request for a potential cure of hepatitis B virus (HBV) infection. Written comments are expected this Fall.
The Pre-IND request was made based on promising data from a proof-of-concept study conducted in chimeric mice, considered by some scientific experts to be the ‘gold standard’ animal model to evaluate HBV cure.
Dr. Mark Dybul, a prominent expert in viruses and Executive Vice Chairperson of the Board of Enochian BioSciences, said, “As a long-time researcher, clinician, and leader of large global disease programs, I am very pleased that the FDA accepted our request to provide feedback to our Hepatitis B development program, and welcome the agency’s input. We are encouraged by the novel mechanism of action, called Hijack RNA that shows promise as a potential platform technology for coronaviruses (including the cause of COVID-19), influenza and HBV, and are exploring its use against HIV.”
Dr. Carol Brosgart, Clinical Professor of Medicine, Epidemiology and Biostatistics, UCSF and former Senior Advisor for Science and Policy to the Division of Viral Hepatitis at the Centers for Disease Control and Prevention, said, “The impressive results in the premier animal model gives me great hope that we are on track to develop a commercial product that could potentially cure HBV infection, a disease that causes chronic liver damage in ~350 million people globally and kills nearly 1 million people each year.” Dr. Brosgart also served as former Vice President of Clinical Research at Gilead Sciences, responsible for HIV and HBV Drug Development, and is a Board Director of Enochian BioSciences.
About Enochian BioSciences, Inc.