Precision BioSciences Expands ELIMINATE-B Trial in EU

Durham, North Carolina, U.S. | April 15, 2026

Precision BioSciences has announced a significant clinical and regulatory milestone with the approval of Clinical Trial Applications (CTA) to expand its ELIMINATE-B trial into France and Romania, advancing the development of PBGENE-HBV, a first-in-class in vivo gene editing therapy for chronic hepatitis B. This expansion strengthens the company’s global clinical footprint and supports broader patient enrollment in a trial designed to deliver a potential functional cure for hepatitis B by eliminating viral cccDNA, the root cause of persistent infection. The development underscores the growing momentum of gene editing technologies in treating chronic viral diseases, positioning Precision BioSciences at the forefront of next-generation therapeutic innovation.

European CTA Approval Accelerates Global Clinical Expansion

The CTA approvals in France and Romania mark a critical step in expanding the ELIMINATE-B Phase 1/2 clinical trial, enabling Precision BioSciences to initiate new trial sites and accelerate patient recruitment across Europe. These additions complement existing trial locations in the United States, United Kingdom, Moldova, New Zealand, and Hong Kong, significantly enhancing the global reach of the study.

The company has confirmed that site initiation activities are already underway, with patient screening expected to begin in the second quarter of 2026. This regulatory milestone reflects strong alignment with international clinical standards and GCP requirements, supporting efficient trial execution and data generation across multiple regions.

PBGENE-HBV Targets Root Cause of Chronic Hepatitis B

PBGENE-HBV represents a groundbreaking approach in hepatitis B treatment, utilizing Precision’s proprietary ARCUS® gene editing platform to directly target and eliminate covalently closed circular DNA (cccDNA), the persistent viral reservoir responsible for chronic infection. Unlike current therapies that primarily suppress viral replication, PBGENE-HBV is designed to achieve a functional cure by removing the source of viral replication and inactivating integrated HBV DNA.

Chronic hepatitis B affects hundreds of millions of people worldwide and remains a leading cause of liver disease, cirrhosis, and cancer. Existing treatments rarely achieve sustained viral clearance, with less than 3% of patients reaching functional cure under standard therapies, highlighting the urgent need for innovative solutions.

Advancing First-in-Class Gene Editing Innovation

The ELIMINATE-B trial is the first human clinical study evaluating a gene editing therapy specifically designed to eliminate cccDNA, positioning PBGENE-HBV as a potentially transformative treatment in infectious disease medicine. The therapy is being evaluated across multiple dose levels and treatment regimens, with the goal of demonstrating sustained loss of HBV DNA and long-term disease remission, which are considered key endpoints for regulatory approval.

Notably, the program has already received FDA Fast Track designation, further supporting its accelerated development pathway. The expansion into additional European countries reflects growing investigator interest and reinforces the therapy’s potential to reshape the standard of care for chronic hepatitis B.

Strategic and Regulatory Implications for Biopharma Innovation

The expansion of the ELIMINATE-B trial highlights broader trends in the biopharmaceutical industry, including the globalization of clinical trials, increasing adoption of gene editing technologies, and focus on curative therapies. By advancing a therapy that targets the underlying cause of disease rather than symptoms, Precision BioSciences is contributing to the evolution of precision medicine and next-generation biologics. The successful execution of this trial could have far-reaching implications for regulatory pathways, clinical practice, and future research in gene editing and infectious diseases.

Precision BioSciences’ expansion of its ELIMINATE-B trial into Europe marks a pivotal moment in the development of curative gene editing therapies for chronic hepatitis B. With strong regulatory support, a growing global trial network, and a novel mechanism targeting the root cause of infection, PBGENE-HBV represents a promising advancement in the fight against one of the world’s most persistent viral diseases. As the trial progresses, its outcomes could significantly influence clinical practice, regulatory strategies, and the future of gene-based therapeutics, offering new hope to millions of patients worldwide.

Source: Precision BioSciences press release