Vaxart Inc (NASDAQ:VXRT) stock surged 70% after the clinical-stage biotechnology company reported positive topline results from its Phase 1 trial evaluating second-generation oral pill norovirus vaccine constructs.
The trial showed that Vaxart’s second-generation vaccine constructs significantly increased norovirus blocking antibody assay (NBAA) titers compared to first-generation constructs. The GI.1 construct demonstrated a 141% increase in NBAA titers, while the GII.4 construct showed a 94% increase at the higher dose level.
"Consistent with what we previously demonstrated in animal models, these clinical data prove that our second-generation constructs increased antibody titers in humans," said Sean Tucker, Vaxart’s Founder and Chief Scientific Officer. He added that these significant increases give the company "high confidence that our second-generation constructs will provide even greater protection against infection."
The open-label trial involved 60 healthy volunteers randomized into three groups of 20 each, receiving either first-generation constructs, an equivalent dose of second-generation constructs, or a lower dose of second-generation constructs. All vaccine candidates were well-tolerated with no vaccine-related serious adverse events reported.
Vaxart CEO Steven Lo stated that the company believes its second-generation norovirus oral pill vaccine candidate "has the potential to provide first-in-class or best-in-class protection" against norovirus, for which there is currently no approved vaccine.
The company plans to incorporate these results into ongoing discussions with potential partners. With appropriate funding or partnership, Vaxart expects to conduct a Phase 2b study potentially beginning in the second half of 2025, followed by a Phase 3 trial as early as 2026.
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