Key Findings
PBGENE-HBV achieved pgRNA loss to undetectable levels in 100% of evaluable patients at the 0.4 mg/kg dose. This effect was durable, with 100% of patients who had at least six months of follow-up maintaining undetectable pgRNA through the September 28, 2026, data cutoff. Additionally, 100% of evaluable patients showed a treatment effect as measured by HBsAg reduction.
Technical Details
The Phase 1 ELIMINATE-B study involved 25 patients receiving a total of 59 administrations across four dose levels. Technical highlights include:
- pgRNA Reduction: Out of 12 evaluable patients with detectable baseline pgRNA, 11 (92%) reached undetectable levels. One patient at 0.65 mg/kg showed a 95% reduction.
- HBeAg-positive Efficacy: An HBeAg-positive patient, typically difficult to treat due to higher viral loads, achieved undetectable pgRNA from a baseline of 3.7-log copies/mL (5,750 copies/mL) following the second administration at 0.4 mg/kg.
- cccDNA Elimination: Paired liver biopsies from two patients at the 0.4 mg/kg dose showed reductions in cccDNA of approximately 1-log (10-fold) and 1.5-log (35-fold).
- Safety: No dose-limiting toxicities were reported across the 59 administrations.
Background and Context
PBGENE-HBV utilizes the proprietary ARCUS platform for in vivo gene editing. It is designed to target and eliminate covalently closed circular DNA (cccDNA), which is the root cause of chronic hepatitis B. The data was presented by lead investigator Man Fung Yuen, MD, Ph.D., at the AASLD The Liver Meeting 2026.
Significance and Outlook
The consistency of the 0.4 mg/kg dose results provides the basis for advancing to a global Phase 2 study. The upcoming trial will evaluate cure rates—defined by sustained undetectable HBV DNA—following a finite course of treatment and the cessation of nucleos(t)ide analogs, aiming to eliminate the need for daily medication.
Source: https://uk.finance.yahoo.com/news/precision-biosciences-announces-breaking-pbgene-120000321.html
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