Vaxart(US:VXRT) Globenewswireยท2025-09-10 20:54Core Insights - Vaxart, Inc. reported positive data from its Phase 1 clinical trial for second-generation oral norovirus vaccine constructs, showing significant increases in fecal IgA responses compared to first-generation constructs [1][4][5] Group 1: Vaccine Efficacy - The second-generation vaccine candidates demonstrated a 25-fold increase in GII.4 fecal IgA response and a 10-fold increase in GI.I fecal IgA response at high doses after a single tablet administration [2] - At low doses, the second-generation constructs showed an 8-fold increase in GII.4 fecal IgA response and a 7-fold increase in GI.I fecal IgA response [2] - The fecal IgA increases from second-generation constructs were significantly higher than the first-generation constructs, which showed a 13-fold increase for GII.4 and a 6-fold increase for GI.1 [3] Group 2: Immunological Responses - The data indicates that the second-generation constructs induce more robust immunologic responses, which are critical as they correlate with protection from norovirus infection [4][5] - The first-generation constructs achieved a statistically significant 30% relative reduction in infection compared to placebo, suggesting that the enhanced fecal IgA and blocking antibody responses from the second-generation constructs may lead to improved efficacy [4] Group 3: Market Potential and Future Plans - Norovirus is a leading cause of acute gastroenteritis globally, with approximately 685 million infections annually, including 20 million in the U.S., leading to an estimated economic burden of $60 billion worldwide and $10 billion in the U.S. [7] - Vaxart aims to secure partnerships or funding to conduct a Phase 2 trial for these constructs, with plans for a Phase 2b safety and immunogenicity study potentially starting before the end of 2025 [6] - The company is positioned to develop oral vaccines for various diseases, including norovirus, and has filed broad patent applications for its proprietary technology [9]