Vaxart, Inc. announced that it has dosed the first subject in the Phase 2 clinical trial of its oral tablet bivalent norovirus candidate. The dose-ranging study is designed to identify a vaccine dose for a potential Phase 3 clinical trial. As previously reported, Vaxart's bivalent vaccine candidate demonstrated robust immunogenicity, with an IgA ASC response rate of 78% for the GI.1 strain and 93% for the GII.4 strain, with no interference observed.

This Phase 2 clinical trial is expected to enroll approximately 135 healthy adults at three sites in the United States. The first 10 subjects will receive open label high-dose vaccine and the remaining subjects will be randomized to high- or low-dose vaccine (N=50 for each arm) or placebo (N=25). The primary endpoints are safety and immunogenicity with the objective of determining dose levels for Phase 3 development.

Vaxart expects to report topline data from the Phase 2 study in mid-2023. Vaxart's bivalent norovirus oral tablet candidate is differentiated from other norovirus vaccines in development because it generates both systemic and mucosal immunity, is delivered through the mouth and is stable at room temperature, making it much easier to distribute and administer than injected vaccines.