Precision BioSciences, Inc. (DTIL) has unveiled landmark clinical data from its ELIMINATE-B study, showing for the first time that a therapeutic agent can directly eliminate and inactivate cccDNA— the root source of hepatitis B viral replication— in patient liver biopsies.
A Breakthrough in Hepatitis B Treatment
The new biopsy results demonstrated a 10-fold reduction in cccDNA transcripts after just two doses of PBGENE-HBV. In the small fraction of cccDNA that remained, the therapy introduced indels that permanently knocked out viral polymerase function, effectively halting replication. These findings mark the first clinical evidence of a treatment modality achieving direct cccDNA elimination.
Biomarker Validation and Patient Outcomes
The study also confirmed pgRNA as a reliable biomarker for cccDNA elimination. All patients with detectable pgRNA at baseline experienced complete loss after treatment, both in blood samples and liver biopsies. Additionally, 100% of patients showed substantial declines in HBsAg, a key indicator of antiviral activity, with durable responses lasting up to a year in the longest-treated patient.
Safety Profile and Manageability
Across 38 doses administered to 16 patients across 5 cohorts, PBGENE-HBV demonstrated a manageable safety profile. Common side effects included infusion-related reactions, while more serious events such as hypotension were addressed with protocol adjustments like slower infusion rates and steroid support. No dose-limiting toxicities were observed.
Looking Ahead
Precision BioSciences plans to expand patient enrollment and collect additional biopsy data to strengthen evidence of cccDNA elimination. The company is preparing for Part 2 of the ELIMINATE-B trial, which will explore nucleoside analog withdrawal and optimize dosing schedules. Updates are expected by year-end 2026.
PBGENE-HBV, developed using Precision's proprietary ARCUS genome editing platform, is the first clinical-stage program designed to directly eliminate cccDNA. It has been granted Fast Track designation by the FDA, aligning with regulatory guidance that eradication of HBV DNA is the optimal endpoint for approval.
DTIL has traded between $3.53 and $8.82 over the past year. The stock closed Tuesday's trading at $7.58, up 4.84%. During overnight trading the stock is at $8.30, up 9.50%.
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