The U.S. FDA has granted fast track designation for Precision BioSciences’ lead in vivo gene editing program designed to cure chronic hepatitis B by eliminating cccDNA, the key source of replicating hepatitis B virus (HBV), and inactivating integrated HBV DNA in hepatocytes.
North Carolina-based Precision is evaluating PBGENE-HBV in the ongoing global phase 1 ELIMINATE-B trial, with clinical investigation in the U.S., Moldova, Hong Kong, New Zealand, and the UK. The company anticipates sharing updates on the full low-dose cohort, including multiple dose administrations, and data from higher dose levels throughout 2025.
According to Precision, PBGENE-HBV is the first and only potentially curative gene editing program to enter clinical investigation that is specifically designed to eliminate cccDNA and inactivate integrated HBV DNA. Precision’s proprietary ARCUS genome editing platform, designed to offer a “more sophisticated” gene edit, differs from other technologies in the way it cuts, its smaller size, and its simpler structure.
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