Precision Biosciences has gained the approval of its clinical trial application (CTA) in Hong Kong to study PBGENE-HBV, a gene editing programme, in the ELIMINATE-B Phase I trial for curing chronic hepatitis B by targeting covalently closed circular DNA (cccDNA), the virus’s replicative element.
The company is currently recruiting subjects in Moldova and has initiated activation of a clinical site in Hong Kong.
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With its compact design and precision cutting capabilities, PBGENE-HBV specifically targets a highly conserved sequence within the hepatitis B viral genome.
It utilises the ARCUS gene editing platform, delivering a nuclease-encoding mRNA to the liver through lipid nanoparticles. This nuclease targets a conserved sequence within the HBV genome, focusing on the elimination of cccDNA and the inactivation of integrated HBV genomes.
The ARCUS platform, based on a naturally occurring enzyme, has undergone over two decades of optimisation to become a pioneering gene editing tool.
Precision is actively pursuing a global regulatory and clinical operations strategy, having submitted multiple trial applications worldwide.
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By GlobalDataThe company is on track to file a new US investigational drug application (IND) next year as part of its Phase I regulatory strategy for the therapy.
It will continue to provide updates on additional regulatory approvals and the commencement of individual treatment in various markets.
Precision BioSciences Clinical Development head and senior vice-president Dr Murray Abramson said: “We are pleased to receive our second CTA approval for PBGENE-HBV, expanding our ELIMINATE-B trial into a world-class HBV clinical trial site in Hong Kong.
“PBGENE-HBV has been designed to target a viral site that is prevalent across all HBV genotypes, including in Asia, and we believe that this will enable us to evaluate and provide access to as many patients as possible. In addition to Hong Kong, our clinical trial site in Moldova continues to execute as planned, and we look forward to sharing clinical data as it matures throughout 2025.”
