Clinical stage gene editing company Precision BioSciences (Nasdaq:DTIL) announced on Monday that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for PBGENE-HBV, a gene editing therapy designed to eliminate the root cause of chronic hepatitis B.

PBGENE-HBV is the first investigational in vivo gene editing therapy approved to enter clinical trials for this condition in the United States.

With this clearance, Precision will expand its ongoing Phase 1 ELIMINATE-B study to the US, adding Massachusetts General Hospital to clinical sites already active in Moldova, Hong Kong and New Zealand. The trial is evaluating PBGENE-HBV's ability to eliminate cccDNA and inactivate integrated hepatitis B virus DNA in hepatocytes.

The first cohort of patients has been enrolled, with additional doses being administered at the initial dose level of 0.2 mg/kg. The company plans to escalate to a higher dose level in a second cohort to determine the optimal dosing strategy.

Precision expects to further expand the trial to the UK and continue recruiting a genetically diverse patient population. The company has reported promising early safety and efficacy data and plans to share further clinical results throughout 2025.