Barinthus Bio has announced promising results from its ongoing Phase 2b HBV003 clinical trial, evaluating VTP-300 in combination with low-dose nivolumab for the treatment of chronic hepatitis B (CHB). The data, presented at The Liver Meeting® 2024, revealed that eight participants experienced complete HBsAg loss, with two achieving functional cure. The study (NCT05343481) includes 121 participants, 69 of whom entered with HBsAg levels below 200 IU/mL.
The HBV003 trial assesses various dosing regimens of VTP-300 alongside low-dose nivolumab, an anti-PD-1 monoclonal antibody. Complete HBsAg loss was defined as HBsAg levels below the lower limit of quantitation. Notably, two participants who discontinued nucleoside analogue (NUC) therapy seroconverted to HBsAb positivity, suggesting a potential shift in immune response.
Potential for Functional Cure
The achievement of functional cure in two participants highlights the potential of VTP-300 as a therapeutic intervention for CHB. Functional cure, characterized by HBsAg loss and HBsAb seroconversion, is a critical goal in CHB treatment, as it signifies viral control and reduced risk of long-term complications such as cirrhosis and hepatocellular carcinoma.
VTP-300: A Novel Immunotherapeutic Approach
VTP-300 is an immunotherapeutic candidate designed to guide T cells to control disease. The combination with low-dose nivolumab aims to enhance the immune response against the hepatitis B virus (HBV). These results suggest that VTP-300, in conjunction with nivolumab, could offer a new strategy for managing chronic HBV infection and potentially achieving lasting remission.
The results from the HBV003 trial offer hope for improved treatment outcomes in patients with chronic hepatitis B, addressing a significant unmet medical need. Further studies are warranted to confirm these findings and to optimize the VTP-300 treatment regimen.
