Precision BioSciences has received approval for a clinical trial application (CTA) to expand its global ELIMINATE-B study, focusing on PBGENE-HBV, an innovative in vivo gene editing therapy aimed at chronic hepatitis B. This recent regulatory clearance marks a significant step forward in the trial’s development.
Expanding European Presence
The approval facilitates the initiation of critical clinical trial sites in France and Romania, complementing existing locations in Hong Kong, Moldova, New Zealand, the UK, and the US. This strategic expansion is expected to enhance patient enrollment and streamline clinical trial execution for the ELIMINATE-B study, ultimately aiming to treat a larger population with PBGENE-HBV.
Timeline for Patient Screening
Precision BioSciences has begun site initiation activities and plans to commence patient screenings in the second quarter (Q2) of 2026. This anticipated timeline reflects the company’s commitment to advancing the trial and delivering potential treatment options to those affected by chronic hepatitis B.
Understanding Chronic Hepatitis B
Chronic hepatitis B is a severe health condition characterized by liver inflammation and persistent infection. Patients face an increased risk of developing liver cancer or cirrhosis, making effective treatment options crucial for improving patient outcomes.
Targeting the Root Cause
PBGENE-HBV is specifically designed to eliminate covalently closed circular deoxyribonucleic acid (cccDNA) and inactivate integrated hepatitis B virus (HBV) DNA. By directly targeting the underlying causes of chronic hepatitis B, the therapy aims to offer a curative solution for affected patients.
The ELIMINATE-B Trial
The ELIMINATE-B trial investigates PBGENE-HBV at various dosing levels to evaluate its effectiveness as a curative treatment. The program has garnered fast track designation from the US Food and Drug Administration (FDA), which supports the sustained loss of HBV DNA as a key endpoint for potential approval.
Strong Investigator Interest
Cindy Atwell, Chief Development and Business Officer at Precision BioSciences, highlighted the significance of expanding ELIMINATE-B into new sites in France and Romania. She emphasized the strong interest from investigators, particularly following a notable presentation at The Liver Conference 2025. This expansion is expected to enhance the global clinical trial footprint of PBGENE-HBV as the study progresses.
Recent Developments
In February, Precision BioSciences received a “Study May Proceed” notification from the FDA. This approval allows the company to initiate institutional review board (IRB) activities and site activation for its Phase I/II FUNCTION-DMD trial, which focuses on PBGENE-DMD for ambulatory patients with Duchenne muscular dystrophy (DMD).
Conclusion
The expansion of the ELIMINATE-B study marks a significant development in the fight against chronic hepatitis B, positioning Precision BioSciences at the forefront of innovative gene editing therapies. As the trial progresses, the potential to transform patient outcomes remains a promising prospect. With an increasing number of trial sites, the hope is to bring effective treatments to those in need.
Key Takeaways:
- Precision BioSciences expands ELIMINATE-B study to France and Romania.
- PBGENE-HBV targets the underlying cause of chronic hepatitis B.
- First patient screenings expected in Q2 2026.
- The study has received fast track designation from the FDA.
- Strong interest from investigators following recent conferences.
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