Vaxart, Inc. (VXRT), a clinical-stage biotechnology company developing oral vaccines, has completed enrollment in its Phase 1 trial evaluating a second-generation oral norovirus vaccine candidate.
The open-label, dose-ranging study is comparing second-generation vaccine constructs head-to-head with Vaxart's earlier versions. The trial will assess safety and immune responses based on parameters shown to correlate with protection in prior challenge studies.
Topline data is expected in mid-2025, marking a key milestone in the development of a needle-free, shelf-stable pill vaccine to address norovirus, a leading global cause of acute gastroenteritis.
An independent Data and Safety Monitoring Board or DSMB conducted a pre-planned review of interim safety data and recommended the study continue without modification, reinforcing the strong safety profile observed to date.
According to CEO Steven Lo, the second-generation constructs may offer greater potency than earlier versions, bringing the company closer to addressing an area of significant unmet need.
If the Phase 1 trial is successful and backed by a partnership or additional funding, Phase 2 trials could begin as early as the second half of 2025, followed by a potential Phase 3 study in 2026.
Vaxart's oral vaccine platform is designed to eliminate the need for needles, allow room-temperature storage, and support mass vaccination efforts without cold-chain logistics.
In addition to norovirus, the company is developing oral vaccines for coronavirus, influenza, HPV (therapeutic), and other indications.
Currently, VXRT is trading at $0.43 up by 3.49 percent on the Nasdaq.
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