Precision BioSciences has submitted Clinical Trial Applications (CTAs) to initiate a Phase 1 study for its in vivo gene editing therapy, PBGENE-HBV. This therapy aims to potentially cure chronic hepatitis B virus (HBV) by eliminating cccDNA, the primary source of viral replication. Additionally, it inactivates integrated HBV DNA in hepatocytes.
PBGENE-HBV is unique in its approach, directly targeting cccDNA for elimination. It has demonstrated efficacy in preclinical models of hepatitis B, including in non-human primates, considered the most reliable model for human safety prediction.
The Phase 1 trial will assess the safety and efficacy of PBGENE-HBV in humans. It will enroll individuals with chronic hepatitis B and evaluate the therapy’s ability to achieve a functional cure. Results of the trial are expected in 2025.
The CTA submissions highlight Precision BioSciences’ commitment to developing a curative therapy for chronic hepatitis B, a global public health concern affecting an estimated 300 million people. The company has assembled a world-class scientific advisory board and bolstered its clinical team expertise to support the development and execution of the global Phase 1 trial.
Precision BioSciences plans to submit additional regulatory applications globally for PBGENE-HBV as part of its Phase 1 regulatory strategy. Detailed safety data of the clinical candidate and Phase 1 trial plans will be presented in November.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
