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NEWS
Precision BioSciences Receives First Approval of Clinical Trial Application to Initiate PBGENE-HBV First-In-Human Study for the Treatment of Chronic Hepatitis B
Precision BioSciences (NASDAQ: DTIL) has received its first Clinical Trial Application (CTA) approval in Moldova for PBGENE-HBV, marking the first in vivo gene editing program for chronic hepatitis B virus to enter global clinical trials. The program aims to cure chronic hepatitis B by eliminating cccDNA and inactivating integrated HBV DNA in hepatocytes using the proprietary ARCUS® platform. PBGENE-HBV delivers nuclease-encoding mRNA to the liver via lipid nanoparticles, targeting the HBV viral genome. The company is pursuing additional CTA and IND approvals globally to accelerate trial enrollment, aiming to provide a potential cure for nearly 300 million patients living with chronic hepatitis B.
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