Precision BioSciences, Inc. announced on March 17, 2025, that the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) application for PBGENE-HBV. This clearance allows the company to expand its Phase 1 ELIMINATE-B trial into the United States.
PBGENE-HBV is Precision's lead wholly-owned in vivo gene editing program, designed to cure chronic hepatitis B by eliminating cccDNA and inactivating integrated HBV DNA. This marks the first-ever investigational in vivo gene editing therapy cleared to enter clinical trials for chronic hepatitis B in the U.S.
The ELIMINATE-B trial is actively enrolling patients in Moldova, Hong Kong, and New Zealand, and will soon initiate Phase 1 clinical activities in the U.S. at the Liver Center at Massachusetts General Hospital. This IND clearance is the fourth regulatory approval for PBGENE-HBV in four months, validating the company's global development strategy.
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