Open-label FIH study of PBGENE-HBV in patients w/ Chronic Hepatitis B
Research type
Research Study
Full title
A Phase 1, Open-Label, First-in-Human, Dose Escalation (Part 1) and Expansion (Part 2) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of PBGENE-HBV in Participants with Chronic Hepatitis B (ELIMINATE-B)
IRAS ID
1010716
Contact name
Lisa Perry
Contact email
Sponsor organisation
Precision BioSciences, Inc.
Clinicaltrials.gov Identifier
Research summary
The worldwide health organisation (WHO) estimated that 1.2 million people worldwide are newly infected with hepatitis B every year, whilst 254 million people were living with chronic hepatitis B CHB). Due to complications such as cirrhosis and liver cancer, hepatitis B caused 1.1 million deaths in 2022. There are approved medicines that work by suppressing the virus, but there is currently no cure for CHB
PBGENE-HBV is an experimental gene therapy medicinal product. A gene is information required for making proteins or other molecules. The information in PBGENE-HBV is in the form of messenger ribonucleic acid (mRNA), similar to the mRNA naturally found in the body. The mRNA that is in PBGENE-HBV instructs the cells in the liver to make a protein called ARCUS nuclease. This protein is not naturally occurring in the body. The ARCUS nuclease cuts apart the genetic instructions of the Hepatitis B Virus. This causes the cell to turn off or remove the virus, which may treat or even cure CHB.
The study will include approximately 42 patients with CHB that will all receive PBGENE-HBV. The trial is split into two parts, starting with a dose increase part. Up to 5 groups of 3 to 6 patients will get up to 3 doses of PBGENE-HBV in part 1. If considered safe Part 2 will include 12 additional patients. Part 2 may give some patients from part 1 the chance to receive another 2 doses.
The study will see how well the treatment works and what, if any, side effects happen.
The study will take 48 weeks, but may take up to 96 weeks depending on response to study treatment.
REC name
London - Brent Research Ethics Committee
REC reference
25/LO/0052
Date of REC Opinion
28 Mar 2025
REC opinion
Further Information Favourable Opinion