Precision BioSciences Inc. (NASDAQ: DTIL) received regulatory approval to expand its ELIMINATE-B clinical trial of PBGENE-HBV to include sites in France and Romania, the company announced.

The Clinical Trial Application approvals allow the gene editing company to add the two European countries to its global hepatitis B trial, which already operates sites in the United Kingdom, Moldova, New Zealand, Hong Kong and the United States.

Site initiation activities are underway, with initial patient screening expected in the second quarter of 2026, according to the press release. The company stated the expansion aims to support continued patient enrollment in the trial.

"Expanding ELIMINATE-B into hepatitis sites in France and Romania is an important step in the continued development of PBGENE-HBV, the only gene editing therapy uniquely designed to eliminate cccDNA," said Cindy Atwell, Chief Development and Business Officer of Precision BioSciences.

PBGENE-HBV is designed as a treatment for chronic hepatitis B infection and targets the elimination of covalently closed circular DNA, which the company describes as the root cause of chronic hepatitis B. The therapy has received Fast Track designation from the Food and Drug Administration.

The ELIMINATE-B trial is investigating PBGENE-HBV at multiple dose levels across various administrations in patients with chronic hepatitis B. The trial information is available on clinicaltrials.gov under identifier NCT06680232.

Chronic hepatitis B affects the liver and can lead to complications including liver cancer or cirrhosis. Current treatments rarely result in a functional cure, with fewer than three out of 100 patients achieving sustained undetectable levels of hepatitis B surface antigen with standard care.