Precision BioSciences Expands ELIMINATE-B Trial Following Clinical Trial Application Approval in Two European Countries
Precision BioSciences, Inc. a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for high unmet need diseases, today announced that it has received Clinical Trial Application (CTA) approval to expand the ongoing global ELIMINATE-B clinical trial of PBGENE-HBV. The regulatory authorization will allow Precision to initiate important hepatitis B clinical trial sites in France and Romania. This expansion broadens the trial’s global footprint deeper into Europe, adding to existing clinical trial sites in the United Kingdom, Moldova, New Zealand, Hong Kong and the United States.
The Company expects the addition of clinical trial sites in France and Romania to support continued patient enrollment and clinical execution in ELIMINATE-B with the goal to treat as many clinical trial patients as possible with PBGENE-HBV. Site initiation activities are underway, with initial patient screening expected in Q2 2026.
Expanding ELIMINATE-B into hepatitis sites in France and Romania is an important step in the continued development of PBGENE-HBV, the only gene editing therapy uniquely designed to eliminate cccDNA,” said Cindy Atwell, Chief Development and Business Officer of Precision BioSciences. “Given the strong investigator interest in PBGENE-HBV, especially following the late breaker oral presentation at The Liver Conference 2025, these new trial sites will build on our existing global clinical trial footprint as we advance PBGENE-HBV through the ELIMINATE-B trial.
About Chronic Hepatitis B
Chronic hepatitis B virus causes inflammation and damage to the liver, leading to chronic infection and increased risk of death from liver cancer or cirrhosis. There is no cure for chronic hepatitis B, and current treatments rarely result in a functional cure, primarily due to persistence of viral DNA in the liver. In patients with chronic hepatitis B, genetic material of the virus is converted within infected liver cells into cccDNA that acts as the only template to make new infectious viral particles.
Hepatitis B virus also inserts fragments of its DNA into the human genome of infected liver cells. These integrated fragments are viral replication incompetent and cannot produce new infectious virus. Both cccDNA and integrated HBV DNA produce the viral protein, hepatitis B surface antigen (“HBsAg”), which is secreted into the blood.
Historically, the focus for drug development and regulatory approval of drugs for chronic hepatitis B has relied on the suppression of HBsAg. Achieving undetectable HBsAg may lead to a functional cure if there is no rebound in HBV DNA or HBsAg after drug treatment has been discontinued for at least six months, but this is achieved in less than three out of 100 patients treated with the current standard of care.
Since cccDNA is the only source of infectious particles (HBV DNA), we believe that elimination of cccDNA could result in a cure of chronic hepatitis B. Sustained loss of HBV DNA alone as a result of cccDNA elimination is also a potentially approvable endpoint for the FDA and highly relevant for PBGENE-HBV.
About PBGENE-HBV, A Viral Elimination Program
PBGENE-HBV is Precision’s wholly owned in vivo gene editing program under investigation in a global first-in-human clinical trial, which is designed to be a potentially curative treatment for chronic hepatitis B infection. PBGENE-HBV is the first and only potentially curative gene editing program to enter the clinic that is specifically designed to eliminate the root cause of chronic hepatitis B, cccDNA, while inactivating integrated HBV DNA.
Elimination of cccDNA results in HBV cure as cccDNA is the only source of infectious replication (HBV DNA). The ELIMINATE-B trial is investigating PBGENE-HBV at multiple dose levels across a number of administrations per dose level in patients with chronic hepatitis B. PBGENE-HBV has been granted Fast Track designation by the FDA.
PBGENE-HBV is the only clinical stage program targeting the elimination of cccDNA leading to sustained loss of HBV DNA. The FDA has previously provided guidance that sustained loss of HBV DNA is an approvable endpoint for chronic hepatitis B.
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