Precision BioSciences Presents Data from the Phase 1 ELIMINATE-B Trial

Precision BioSciences, a clinical-stage gene editing company, presented clinical data from the Phase 1 ELIMINATE-B trial of PBGENE-HBV in patients with chronic Hepatitis B. Data was presented at the International Coalition to Eliminate HBV (ICE-HBV) “HBV Cure Symposium” Meeting in Berlin, Germany.

PBGENE-HBV is Precision’s wholly owned in vivo gene editing program under investigation in a global first-in-human clinical trial, which is designed to potentially cure chronic hepatitis B infection. 

PBGENE-HBV is the first and only potentially curative gene editing program to enter clinical investigation that is specifically designed to eliminate cccDNA and inactivate integrated HBV DNA. Lipid nanoparticle technology for PBGENE-HBV has been provided by Acuitas Therapeutics Inc.

The Phase 1 ELIMINATE-B study is currently enrolling HBeAg-negative chronic hepatitis B patients at world-class sites in Moldova, Hong Kong, and New Zealand, and will commence in the U.S.

The goal of the study is to define the optimal dose and number of dose administrations for safely eliminating cccDNA and inactivating integrated HBV DNA. 

With regulatory approval already granted, Precision expects to expand the study to clinical trial sites in the U.S. and U.K. and continue accelerating recruitment and evaluation of a genetically diverse patient population in the Phase 1 study.

Cassie Gorsuch, PhD, Chief Scientific Officer at Precision BioSciences, said, “We believe the clinical profile we have observed so far demonstrates the first evidence of substantial HBsAg reductions by a novel therapeutic approach designed to directly target cccDNA for elimination and inactivate integrated HBV DNA in patients with chronic Hepatitis B. In the ELIMINATE-B trial following multiple administrations across two dose levels (Cohort 1 and Cohort 2), PBGENE-HBV has been well-tolerated and active. With the recent initiation of dosing patients in Cohort 3, we remain on track to provide further data updates in 2025.”

The presentation is available as a Presentation under the “Scientific Publications” page of the company’s website.