The trial aims to determine the dosing interval, optimal dose and number of administrations for curing chronic hepatitis B. Credit: Gorodenkoff/Shutterstock.com.

Precision BioSciences has activated its first clinical trial site in the US to assess PBGENE-HBV as part of the ELIMINATE-B Phase I study.

The new site at Massachusetts General Hospital in Boston is now recruiting subjects.

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Precision BioSciences chief development and business officer Cindy Atwell said: “Chronic hepatitis B remains one of the most pressing global health challenges with millions of patients facing risk of liver disease progression to cirrhosis and liver cancer.

“As we continue to advance our ELIMINATE-B trial through Cohort three, we are thrilled to open recruitment at Massachusetts General Hospital, a world-renowned institution with deep expertise in running clinical studies in hepatitis.

“Initiation of our first US trial site represents an important step in expanding our study to patients in the US. Looking ahead, we remain on track to provide further data updates on the ELIMINATE-B study in 2025.”

The Phase I open-label, multi-part trial is designed to assess the tolerability and safety of PBGENE-HBV.

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It aims to determine the dosing interval, optimal dose and number of administrations required to achieve cures in participants with chronic hepatitis B.

Researchers at Massachusetts General Hospital are assessing a gene-editing technique that directly targets the virus at its source.

PBGENE-HBV is Precision’s wholly owned in vivo gene editing programme currently being investigated in a first-in-human study, with the aim of curing chronic hepatitis B infection.

An estimated 300 million people worldwide are affected by chronic hepatitis B.

PBGENE-HBV is said to be the first curative gene editing programme to enter clinical investigation and is designed to eliminate covalently closed circular DNA (cccDNA) and inactivate integrated HBV DNA.

Acuitas Therapeutics provided lipid nanoparticle technology utilised for PBGENE-HBV.

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