Precision BioSciences reports positive Phase 1 PBGENE-HBV data; first human biopsy evidence of viral gene editing

PRECISION BIOSCIENCES INC

Phase 1 ELIMINATE-B trial: 9 patients across 0.2, 0.4, 0.8 mg/kg doses (22 total administrations); no dose-limiting toxicities observed.
All patients showed HBsAg reductions; Cohort 3 (0.8 mg/kg) had steep early declines with cumulative effect – one patient achieved 64% decrease.
Paired liver biopsy from Cohort 2 confirmed ARCUS-mediated indel edits in HBV DNA – first direct human evidence of viral gene editing.
Transient infusion reactions and asymptomatic platelet fluctuations; one reversible Grade 3 AST elevation resolved within 3 days.
Cohort 3 dosing to complete Q1 2026; next step: Part 2 expansion with optimized regimen and mandatory paired biopsies.

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