Precision BioSciences has reported initial outcomes from the ELIMINATE-B trial of PBGENE-HBV, a gene editing programme for treating chronic Hepatitis B patients who are HBeAg-negative.
In cohort one, the lowest dose level of PBGENE-HBV was administered to three subjects at a dose of 0.2mg/kg and was found to be safe and well tolerated.
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Subjects had varying baseline characteristics and did not experience any serious treatment-related adverse events following the first administration.
In addition, a significant decrease in Hepatitis B surface antigen (HBsAg) was observed in two out of the three subjects after the first administration at dose level 1.
The trial was tailored to evaluate the therapy at multiple ascending dose levels, with three dose administrations per level in subjects with this condition.
Its dosing schedule allows for two additional administrations at the current dose level while concurrently investigating the next higher level.
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By GlobalDataPrecision aims to define the optimal dose and number of administrations for the elimination of covalently closed circular DNA (cccDNA), in addition to the inactivation of integrated HBV DNA.
Precision BioSciences CEO and president Michael Amoroso said: “This marks an important step forward for Precision in a large patient population and the second clinical validation of Arcus in vivo gene editing following the recent clinical data from the OTC-HOPE study being conducted by our partner iECURE in a dire rare disease.”
The trial is currently enrolling subjects across multiple international sites, including Hong Kong, New Zealand, and Moldova, with plans to expand to the UK and the US.
Precision is on track to provide further updates and detailed clinical data throughout the year.
PBGENE-HBV is developed using the company’s ‘Arcus’ genome editing platform. It includes an Arcus-encoding mRNA, which is encapsulated in a lipid nanoparticle.
