Precision BioSciences Reports First Clinical Evidence of cccDNA Elimination in Hepatitis B Trial
Event summary
- Precision BioSciences presented late-breaking clinical data from the ELIMINATE-B study at EASL 2026, showing first-ever evidence of cccDNA elimination in chronic hepatitis B patients.
- 16 patients across 5 cohorts received 38 doses of PBGENE-HBV, demonstrating a 1-log reduction in cccDNA transcripts after two doses at 0.4 mg/kg.
- 100% of patients (n=15) experienced substantial HBsAg declines, with durable responses observed in some patients for over 1 year.
- No dose-limiting toxicities were observed, though Grade 3 hypotension was reported in one patient at the highest dose cohort (0.8 mg/kg).
- Precision plans to treat more patients in Part 1 of the trial and expects to provide additional updates by the end of 2026.
The big picture
Precision BioSciences' data represents a potential paradigm shift in hepatitis B treatment, moving from lifelong viral suppression to a finite cure. The company's ARCUS platform is uniquely positioned to target cccDNA, the root cause of viral replication, addressing a critical unmet need in the field. The strategic significance lies in the potential to disrupt the chronic care model for hepatitis B, aligning with FDA guidance on viral eradication as the optimal endpoint for approval.
What we're watching
- Clinical Validation
- Whether the observed cccDNA elimination and HBsAg declines can be sustained and replicated in a larger patient population.
- Regulatory Pathway
- How the FDA will interpret these data in the context of its guidance on HBV DNA eradication as an approvable endpoint.
- Execution Risk
- The pace at which Precision can optimize dosing schedules and advance into Part 2 of the ELIMINATE-B trial.
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