Precision BioSciences, Inc. announced on October 24, 2024, that it received Clinical Trial Application (CTA) approval in Moldova for its lead candidate, PBGENE-HBV. This approval enables the company to initiate a Phase 1 study evaluating PBGENE-HBV as a potential curative treatment for chronic hepatitis B.
PBGENE-HBV is Precision's wholly-owned in vivo gene editing program, uniquely designed to eliminate cccDNA and inactivate integrated HBV DNA, which are the root causes of chronic hepatitis B. This marks the first clinical stage gene editing program for chronic hepatitis B to directly target these viral components.
The company has opened the Phase 1 clinical program in Moldova and is actively working towards dosing patients. Precision BioSciences plans to leverage its robust preclinical safety package to pursue additional CTA and IND approvals globally, aiming to accelerate trial enrollment and generate clinical data in 2025.
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