Vaccitech announced positive topline final data from the HBV002 study,NCT04778904 , a Phase 1b/2a clinical trial of VTP-300 in people with chronic Hepatitis B,HBV, infection. The completed trial, which included 55 patients with chronic hepatitis B, supported the generally favorable tolerability profile previously reported with VTP-300, with no incidents of VTP-300-related Grade 3 adverse events or product-related serious adverse events following study dosing. VTP-300 was observed to induce meaningful, sustained reductions of Hepatitis B surface antigen (HBsAg) in patients with chronic HBV. Declines were most prominent in patients with lower baseline HBsAg. The final results of the immunology assays are currently being analyzed and the full data, including tolerability and immunogenicity results, will be presented at the upcoming EASL Congress, June 21-24, 2023. "The safety data and HBsAg reductions in the HBV002 study are very encouraging and we look forward to sharing the full data set, including immune responses, at the EASL conference," said Bill Enright, CEO of Vaccitech. "Less than 10% of people with chronic HBV reach a functional cure with current therapies. We believe VTP-300 has the potential to be a critical component of functional cure for HBV, potentially eliminating the need for chronic treatment. Our ongoing trials are exploring dosing, including an additional booster, and combination approaches with readouts expected towards the end of the year."
Published first on TheFly
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