Precision BioSciences, Inc. announced on September 30, 2024, the submission of Clinical Trial Applications (CTA) to initiate a Phase 1 study for PBGENE-HBV. This wholly-owned in vivo gene editing program is designed to potentially cure chronic hepatitis B virus (HBV) by eliminating covalently closed circular DNA (cccDNA) and inactivating integrated HBV DNA in hepatocytes.
The company highlighted that PBGENE-HBV represents the first gene editing approach for chronic hepatitis B to reach this stage. This therapeutic strategy aims to target the root cause of the disease, a significant advancement over current standard-of-care treatments that rarely lead to a functional cure.
Precision BioSciences plans to share final clinical candidate safety data and detailed plans for the Phase 1 trial in November 2024. The company is pursuing a global regulatory strategy, supported by robust non-human primate safety studies and efficacy in various preclinical models.
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