Precision BioSciences, Inc. on November 15, 2024, presented preclinical data supporting the advancement of PBGENE-HBV into clinical development and outlined the design of its first-in-human study, ELIMINATE-B, for chronic hepatitis B patients.
The preclinical results demonstrated compelling safety and selectivity, highly efficient editing, and confirmation of PBGENE-HBV's mechanism to eliminate cccDNA and viral DNA integrated into hepatocytes. These data formed the robust package submitted to regulators for the global Phase 1 trial.
The ELIMINATE-B study is a global, multi-site, Phase 1 clinical trial designed to evaluate up to 45 HBV patients who are HBeAg-negative and virologically suppressed on nucleos(t)ide analogues. The trial will assess safety and efficacy, measured by durable reduction of key viral biomarkers, with initial clinical data anticipated in 2025.
Regulatory authorization is in place, with clearance to initiate the Phase 1 study in Moldova already secured. The company anticipates a U.S. Investigational New Drug (IND) filing in 2025, further expanding the global reach of the trial.
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