First clinical proof of cccDNA elimination positions PBGENE-HBV as a potential functional cure — Phase 2 design and durability data will determine if the signal holds

Precision BioSciences is a clinical-stage biotechnology company developing a gene therapy for chronic hepatitis B that is not yet approved.

PBGENE-HBV has produced what no other therapeutic has achieved in the clinic: liver biopsy-confirmed elimination of cccDNA, the viral reservoir that makes chronic hepatitis B incurable with current antivirals. Whether this translates into a registrational functional cure depends on durable HBsAg loss — and eventually viral cure — in the planned Part 2 withdrawal study. The primary risk is that early biomarker signals, compelling as they are, come from a small single-arm trial where durability beyond 12 months and the magnitude of antiviral response at higher doses remain uncharacterized.