Gene editing company Precision BioSciences Inc (NASDAQ: DTIL) announced on Monday that it has submitted Clinical Trial Applications (CTA) for PBGENE-HBV, marking the first gene-editing approach targeting chronic hepatitis B virus (HBV).

PBGENE-HBV is designed to eliminate cccDNA, the root cause of HBV replication, while inactivating integrated HBV DNA in hepatocytes.

This proprietary gene-editing program, powered by the company's ARCUS platform, is aimed at potentially curing HBV. Precision expects to share safety data and Phase 1 plans in November, ahead of the American Association for the Study of Liver Diseases (AASLD) Annual Meeting.

Chronic HBV affects over 300 million people globally, with no curative treatments currently available. PBGENE-HBV seeks to address this need by offering a highly specific and novel therapeutic approach that targets the core drivers of the disease, potentially leading to functional cures.