Barinthus Bio's VTP-300 Trials Demonstrate Ability to Achieve Undetectable HBsAg levels and Statistical Significance in Lowering HBsAg Levels in People with Chronic Hepatitis B

Core Insights - Barinthus Biotherapeutics presented updated data from two clinical trials for chronic hepatitis B (CHB) at the EASL Congress 2024, highlighting the efficacy of VTP-300 in maintaining low HBsAg levels and the potential for NUC therapy discontinuation [4][6][9] Group 1: Trial Results - In the HBV003 trial, 67% of participants had HBsAg levels below 10 IU/mL, and 19% had undetectable HBsAg at the end of treatment or later, with 76% eligible for NUC therapy discontinuation [1][5] - The IM-PROVE II trial showed a statistically significant difference in HBsAg levels between the VTP-300 treatment group and placebo at 24 weeks post-treatment, with 84% of VTP-300 participants discontinuing standard NUC therapy compared to 53% in the placebo group [1][2][8] Group 2: Treatment Tolerability - Both VTP-300 and imdusiran were generally well-tolerated, with no serious adverse events reported, and the most common treatment-related adverse event was thyroid dysfunction in 9% of participants [5][6][8] - Robust T cell responses were observed, indicating a strong immune response to the treatment [5][6] Group 3: Future Directions - The company is eager to see further data from the ongoing trials, particularly regarding the combination of VTP-300 with nivolumab, which could advance towards a potential functional cure for hepatitis B [3][6] - An additional cohort in the IM-PROVE II trial is expected to provide preliminary data in the second half of 2024, focusing on the combination of imdusiran and VTP-300 with low doses of nivolumab [13]