Precision BioSciences, a North Carolina-based CGT developer, has secured approval from Moldovan health authorities to initiate a clinical trial for PBGENE-HBV, an innovative in vivo gene editing therapy designed to combat chronic hepatitis B (HBV). This therapy targets the covalently closed circular DNA (cccDNA), the primary driver of the virus, with the goal of achieving a functional cure.
Novel Approach to HBV Treatment
Unlike current antiviral treatments that merely suppress HBV replication, PBGENE-HBV aims to eliminate or disable the viral reservoir. This approach offers the potential for a functional cure or even viral eradication. Early trials have demonstrated promising results, paving the way for this clinical trial in Moldova.
Michael Amoroso, CEO of Precision BioSciences, stated, "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."
Trial Logistics and Expansion Plans
Precision BioSciences intends to begin dosing patients in Moldova shortly, with subsequent plans to broaden the trial beyond the country's borders. The company is optimistic that this treatment could provide a functional cure for hepatitis B, addressing a significant unmet medical need.
HBV Prevalence and Vaccination
Despite widespread vaccination campaigns in many EU countries, chronic hepatitis B remains a significant public health concern, particularly in regions with lower vaccination coverage. A 2022 report from the European Centre for Disease Prevention and Control (ECDC) indicates that specific high-risk populations, such as migrants from HBV-endemic regions, are disproportionately affected. Eastern and Southern European countries often exhibit higher HBV prevalence compared to Western and Northern Europe due to disparities in healthcare access and vaccination rates.
Political Landscape in Moldova
The political climate in Moldova is dynamic, with incumbent President Maia Sandu facing a challenge from pro-Russian candidate Alexandr Stoianoglo. The election results could significantly impact a referendum on EU accession, potentially influencing the clinical trial for PBGENE-HBV. Political instability or changes in healthcare policy could affect regulatory frameworks, timelines, or collaborations with international bodies. Precision BioSciences will need to closely monitor the situation to maintain a stable operational environment during the trial. A victory for Sandu could lead to EU-backed improvements in clinical research infrastructure, while a victory for Stoianoglo could disrupt current healthcare policies and the study.
