Precision BioSciences posts first patient biopsy data proving Hepatitis B viral elimination
Precision BioSciences (NASDAQ:DTIL) unveiled late-breaking clinical data from its ongoing Phase 1/2a ELIMINATE-B trial, delivering what it characterizes as the first-ever human biopsy evidence of a therapeutic agent successfully eliminating and inactivating the root genetic reservoir of chronic hepatitis B.
The Durham, North Carolina-based gene-editing company presented the patient liver biopsy readouts at the European Association for the Study of the Liver (EASL) Congress 2026 in Barcelona, Spain.
The data centered on the company’s lead investigational candidate, PBGENE-HBV, an in vivo gene-editing treatment delivered via lipid nanoparticles designed to permanently clear the virus.
Historically, standard commercial therapies for chronic hepatitis B have been restricted to lifelong viral suppression because they cannot clear covalently closed circular DNA (cccDNA)—the stable, distinct viral genetic structure that hides inside infected liver cells and serves as a continuous template for replication.
Precision's new data demonstrated that PBGENE-HBV directly excised and destroyed this hidden cccDNA reservoir, driving a 1-log (10-fold) reduction in cccDNA-derived viral transcripts.
Furthermore, in the trace fraction of less than 1% of cccDNA that evaded direct elimination, the therapy introduced insertions and deletions (indels) that permanently knocked out viral polymerase function, effectively freezing the virus's ability to replicate.
The clinical evaluation also validated pre-genomic RNA (pgRNA) as a reliable biomarker to track the physical clearing of cccDNA from the liver, with PBGENE-HBV achieving total pgRNA loss in 100% of patients who entered the trial with detectable levels.
As of the May 4, 2026 data cut-off, the clinical program had administered 38 cumulative doses to 16 patients across five distinct dosing cohorts.
Management indicated that the drug has demonstrated a clear therapeutic window, presenting a well-characterized and manageable safety profile with zero serious adverse events or unexpected safety signals flagged across the active patient cohorts.
The clinical validation aligns directly with current regulatory frameworks, as the U.S. Food and Drug Administration has previously indicated that the eradication of HBV DNA represents the optimal clinical endpoint for permanent disease cure.
Following the data release, Precision BioSciences plans to accelerate patient enrollment in the higher-dose cohorts of the ELIMINATE-B study as it prepares to transition the genetic asset into subsequent mid-stage international clinical developments.
