Moldova-based HBV Gene Editing Trial: A Trial of Our Times

North Carolina-based CGT developer Precision BioSciences has received a clinical trial application approval from the health regulation authorities of Moldova, where researchers will trial PBGENE-HBV. This new in vivo gene editing therapy is aimed at curing chronic hepatitis B (HBV) by eliminating covalently closed circular DNA (cccDNA), the main driver of the virus.

Unlike current antiviral treatments that suppress HBV replication, the gene therapy aims to eliminate or disable the viral reservoir, offering the potential for a functional cure or eradication. Early trials have shown promise. Michael Amoroso, CEO, Precision BioSciences, said, “We are leveraging our robust regulatory package, which highlights the safety and potent antiviral effects of PBGENE-HBV in a variety of models, including non-human primates, to pursue additional CTA and IND approvals globally. This multi-track approach will enable us to accelerate enrollment into the trial and generate important clinical safety and efficacy data with the aim of bringing a potentially curative treatment to the nearly 300 million patients living with chronic hepatitis B globally.”

Precision BioSciences believes this treatment could offer a functional cure for hepatitis B and plans to begin patient dosing soon before expanding the trial beyond the small Eastern European country.

Despite widespread vaccination campaigns in many EU countries, chronic hepatitis B remains a public health concern in areas with lower vaccination coverage​. A 2022 report from the European Centre for Disease Prevention and Control (ECDC) highlighted that certain high-risk populations, particularly among migrants from HBV-endemic regions, are disproportionately affected. Countries in Eastern and Southern Europe often report higher HBV prevalence compared to those in Western and Northern Europe because of variations in healthcare access and vaccination rates.

It’s worth noting that Moldova’s political environment is highly dynamic. The country’s incumbent President Maia Sandu faces a mounting challenge from pro-Russian candidate Alexandr Stoianoglo, and the results will also have a major influence on a referendum on EU accession. Could this have an effect on the clinical trial for PBGENE-HBV? Certainly. Political instability or shifts in healthcare policy may affect regulatory frameworks, timelines, or collaboration with international bodies. Given the situation, Precision BioSciences will need to remain vigilant in maintaining a stable operational environment during the trial. A victory for Sandu will see the implementation of EU-backed improvements in clinical research infrastructure. Victory for Stoianoglo could result in an upheaval of current healthcare policies and disruption of this first-of-its-kind study.