What's Happening?
Precision BioSciences has presented late-breaking data from its Phase 1 ELIMINATE-B study at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting. The study evaluates PBGENE-HBV,
a gene editing therapy designed to treat chronic Hepatitis B by targeting HBV cccDNA and integrated HBV DNA. The therapy was well-tolerated across various doses, showing no dose-limiting toxicities. Data from the first three cohorts demonstrated dose-dependent antiviral responses, with significant reductions in hepatitis B surface antigen (HBsAg) observed. The study suggests a potential path towards stopping nucleos(t)ide analogs and testing for cure following additional administrations of PBGENE-HBV.
Why It's Important?
The findings from Precision BioSciences' study are significant as they represent a potential breakthrough in the treatment of chronic Hepatitis B, a disease affecting millions globally. Current treatments require lifelong administration and do not eradicate HBV cccDNA. The ability of PBGENE-HBV to directly edit viral DNA and reduce HBsAg levels could lead to a functional cure, offering hope to patients who currently have limited treatment options. This development could also pave the way for new gene editing therapies targeting other viral infections.
What's Next?
Precision BioSciences plans to complete dosing in the third cohort and explore additional dose administrations. The company aims to advance PBGENE-HBV into the Part 2 expansion phase of the ELIMINATE-B study, evaluating the optimized dose regimen in a larger patient population. The goal is to achieve a functional cure by stopping nucleos(t)ide analogues when HBsAg becomes undetectable. Further studies are planned to refine dosing intervals and expand clinical trial sites.
