Clinical Trials

UK-based Barinthus Biotherapeutics has announced data from its ongoing phase 2b HBV003 clinical trial, which was presented at the American Association for the Study of Liver Diseases (AASLD) Meeting 2024.

HBV003 is evaluating different dosing regimens of VTP-300 in combination with low-dose nivolumab in a total of 121 participants. Nivolumab is an anti-PD-1 monoclonal antibody. Since the cutoff date, eight participants have achieved complete HBsAg loss, and two meet the criteria for functional cure. The data further highlights that stronger responses may happen in participants that are treated with the VTP-300 and nivolumab combination.

Dr Chun-Jen Liu, investigator on HBV003 and director of the Hepatitis Research Center and Clinical Trial Center, National Taiwan University Hospital, Taiwan, stated, “Sustained HBsAg loss has proven to be the largest hurdle in getting chronic hepatitis B patients to functional cure. The data we are seeing with VTP-300 is unique because they indicate a durable loss of HBsAg in participants, including two who met the criteria for functional cure. Although the study is still ongoing, these early data may bring us a step closer to potentially allowing some patients with chronic hepatitis B to come off antiviral treatment without their chronic hepatitis B progressing.”