Vaxart Announces Clinical Trial Initiation of Norovirus Oral Pill Vaccine Candidate
Wednesday, March 12, 2025
Vaxart, Inc. announced the initiation of a Phase 1, open label, dose ranging clinical trial evaluating its second-generation oral norovirus vaccine constructs head-to-head against its first-generation constructs.
“We are pleased to initiate a Phase 1 trial for our oral bivalent norovirus vaccine, delivered in a pill formulation, which will seek to demonstrate improved immune responses of our second-generation constructs,” said Steven Lo, Chief Executive Officer of Vaxart. “As norovirus continues to spread across the United States and globally, it has never been more important to address this urgent public health need. With no currently approved vaccines against norovirus, we are committed to advancing what we believe is the most promising norovirus vaccine candidate in clinical development and look forward to reviewing the topline data that is expected as early as mid-2025.”
The Phase 1 trial is an open label, dose ranging clinical study designed to evaluate Vaxart’s second-generation oral norovirus vaccine constructs head-to-head against its first-generation constructs. The study will measure safety and immune parameters that have correlated to protection in the completed norovirus challenge study.
If the Phase 1 trial is successful, and assuming a partnership or other funding, Vaxart expects to conduct a Phase 2 safety and immunogenicity study that could potentially begin as early as the second half of 2025, followed by an End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA). A Phase 3 trial could then begin as early as 2026.
Source: globenewswire.com
