Precision BioSciences has developed PBGENE-HBV, the only therapy in clinical trials specifically designed to eliminate the root cause of chronic hepatitis B viral replication by targeting the cccDNA and integrated HBV DNA.

PBGENE-HBV
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ELIMINATE-B is a phase 1, open-label, first-in-human dose-finding and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of PBGENE-HBV in adult participants with chronic hepatitis B.

ClinicalTrials.gov Identifier
NCT06680232

HBV Currently Lacks a Curative Treatment

Hepatitis B is a leading cause of morbidity in the US and of death globally, with no current curative options.

>2.4 million
HBV infections in the US1,2

>300 million
HBV infections globally1,2

An estimated

15% to 40% of patients

with HBV infection may develop complications, such as cirrhosis, liver failure, or liver cancer, which account for the majority of HBV-related deaths.3

Current HBV treatments require lifelong chronic treatment that may result in viral suppression by reducing circulating HBV DNA, but these therapies do not eradicate HBV cccDNA and therefore rarely lead to cure. Up to 500,000 patients with HBV develop hepatocellular carcinoma (HCC) annually.

PBGENE-HBV:

PBGENE-HBV is the first gene-editing therapy designed to treat chronic hepatitis B by directly targeting HBV cccDNA and integrated HBV DNA.





Reasons to Believe in Precision's Approach for HBV

The only program designed to eliminate cccDNA PBGENE-HBV is the first and only clinical-stage program designed to directly target and eliminate cccDNA — the sole source of new infectious HBV DNA — and to inactivate integrated HBV DNA.
Loss of pgRNA, the biomarker specific to cccDNA and the precursor to HBV DNA
 Patients with detectable pgRNA at baseline have achieved durable loss of pgRNA following treatment 
with PBGENE-HBV, with undetectable blood pgRNA corroborated by post-treatment liver biopsy. Because pgRNA derives entirely from cccDNA, it is the blood biomarker that most directly reflects cccDNA elimination.
Clinical evidence of cccDNA elimination, confirmed in liver biopsies
 Paired liver biopsy data from treated patients demonstrate substantial reductions in cccDNA-derived transcripts. In the cccDNA that remains, gene edits disable polymerase function, rendering the virus replication-incompetent. Editing increases with repeat administration, consistent with a cumulative and permanent effect.
Antiviral activity across dosing cohorts with a manageable repeat-dosing profile
 Consistent with cccDNA elimination, meaningful HBsAg declines have been observed across treated patients regardless of baseline S-antigen levels, with reductions sustained over extended follow-up in the longest-treated patients.

PBGENE-HBV is an investigational therapy that has not been approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority.
Although the safety and efficacy profiles are currently unknown, it is being assessed in the ELIMINATE-B clinical trial.

Hear from Our Experts

ARCUS in vivo gene editing is designed to eliminate cccDNA, the root cause of HBV infection, and enable a potential cure.

An insightful exploration into the HBV landscape, the unique features of ARCUS gene editing among other genetic modalities in development, details regarding the PBGENE-HBV clinical trial, and more.

Clinical Trial Now Enrolling

  1. Nguyen MH et al. Clin Microbiol Rev. 2020;33(2); GSK public epidemiology estimates for cHBV.
  2. Trucchio, Patrick. “Hepatitis B Breakthrough Boom: Navigating a $450-$500 Billion Frontier”, H.C. Wainwright & Co. 14, Feb 2024.
  3. Centers for Disease Control and Prevention. Hepatitis B. CDC Yellow Book 2024: Health Information for International Travel. Accessed October 18, 2024.