WE.SPEED.
ARENSIA Research Clinic is proud to announce that we have dosed the world’s first patient in the ELIMINATE-B trial, marking a significant milestone in the battle against chronic Hepatitis B. This first-in-human study evaluates PBGENE-HBV, an innovative gene-editing therapy designed to eliminate HBV at its source—an approach never before tested in patients.
Initial results are promising. At the lowest dose level, PBGENE-HBV has shown substantial antiviral activity, with a notable reduction in Hepatitis B surface antigen (HBsAg)—a key indicator of viral presence. Most importantly, the treatment has been safe and well-tolerated, with no serious or Grade ≥2 treatment-related adverse events reported among the first three patients. These findings represent the first clinical proof-of-concept for ARCUS-based gene editing in Hepatitis B, underscoring its potential to revolutionize treatment.
With global patient interest at an all-time high, the ELIMINATE-B trial is progressing rapidly. Additional administrations at this dose level are planned, followed by escalations to determine the optimal regimen for viral elimination. As a leader in early-phase patient trials, ARENSIA remains at the forefront of groundbreaking scientific advancements, playing a crucial role in shaping the future of curative treatments for Hepatitis B.
This is just the beginning. The success of PBGENE-HBV could mark a turning point for millions affected by Hepatitis B worldwide. We are humbled and honored to be part of this transformative journey.
First Patient Dosed – ARENSIA Research Clinic (Moldova) has dosed the first patient globally in the ELIMINATE-B trial for PBGENE-HBV.
Groundbreaking Gene Editing Approach – PBGENE-HBV is the first LNP gene editing technology studied for Hepatitis B treatment.
First Proof-of-Concept in Humans – Early data confirms the potential to eliminate and inactivate HBV at its root (cccDNA & integrated DNA).
Safety & Tolerance Confirmed – The initial three patients experienced no serious or Grade ≥2 treatment-related adverse events.
Antiviral Effect at Lowest Dose – A substantial reduction in Hepatitis B surface antigen (HBsAg) was observed after a single administration.
Multi-Dose Escalation Plan – The study allows for three administrations per dose level, with higher doses to follow.
Global Trial Expansion – ELIMINATE-B is being conducted in Moldova, Hong Kong, and New Zealand, with plans for expansion to the U.S. and U.K.
Rapid Patient Enrollment – The first cohort was fully enrolled within a month, reflecting strong patient interest.
The second Clinical Validation for ARCUS – PBGENE-HBV marks another major milestone for Precision BioSciences' in vivo gene editing.
Potential Game-Changer for HBV – If successful, this could be the first curative gene-editing therapy for chronic Hepatitis B.
13.03.2025