Vaxart Doses First Subject in Phase 2 Trial of Bivalent Norovirus Candidate

 Vaxart, Inc. (NASDAQ: VXRT) today 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.

“Initiating the Phase 2 clinical trial of this candidate is an important achievement toward our goal of developing an oral tablet vaccine that may reduce the significant global health threat that norovirus poses to children and seniors,” said Dr. James F. Cummings, MD, Chief Medical Officer at Vaxart. “Results from the Phase 1b clinical trial in healthy adults demonstrate that this candidate stimulates robust IgA antibody secreting cells against the prevalent strains of two norovirus genotypes that cause the majority of norovirus disease. Data from the Phase 2 trial will inform our further clinical development strategy for this promising vaccine candidate targeting a market estimated at more than $10 billion in the United States alone.”

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.

https://www.biospace.com/article/releases/vaxart-doses-first-subject-in-the-phase-2-clinical-trial-of-its-bivalent-norovirus-candidate/