VXRT - Vaxart succeeds in mid-stage trial for oral norovirus shot
2023-07-06 10:33:23 ET
Vaxart ( NASDAQ: VXRT ) announced Thursday that its Phase 2 clinical trial for an oral bivalent norovirus vaccine candidate met all primary endpoints, leading to strong immune responses across all dose levels.
There are currently no approved vaccines for norovirus, which is the most common cause of acute viral gastroenteritis in the U.S.
According to Vaxart ( VXRT ), topline data indicated that the trial participants developed no vaccine-related serious adverse events or dose-limiting toxicities, and the pill was well tolerated.
The U.S.-based trial enrolled 135 healthy adults, out of whom 125 received a high- or medium-dose of the vaccine or placebo, while the rest received the high-dose vaccine.
Data from Day 1 to Day 29 indicated no statistically significant difference in antibody responses linked to medium and high dose arms.
The study, whose final results are expected in H2 2023, as well as Vaxart’s ongoing norovirus challenge study, are designed to support Vaxart's ( VXRT ) bivalent norovirus Phase 2b study for the vaccine.
In anticipation of a future Phase 3 study and a potential Biologics License Application, the company expects to conduct an End-of-Phase 2 meeting with the FDA in 2024, subject to positive safety data from the Phase 2b study.
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Vaxart succeeds in mid-stage trial for oral norovirus shot