Vaxart reports positive topline Phase 2 data of norovirus vaccine candidate

Vaxart announced positive topline data from the dose-ranging Phase 2 clinical trial of its oral pill bivalent norovirus vaccine candidate. Preliminary results of the trial showed robust serum immune responses across all doses at Day 29 relative to Day 1. Both doses showed a similar increase in serum antibody responses with no statistical difference between the medium and high dose arms. Results from this Phase 2 dose-ranging study also demonstrated that the bivalent norovirus vaccine candidate was well tolerated, with a favorable safety profile that included no vaccine-related serious adverse events and no dose limiting toxicity. Collectively, the data from these completed trials have shown immune responses from Vaxart’s oral norovirus vaccine constructs to be strong, long-lasting, and comparable to natural infection. Additional timepoint measures and mucosal data from this study are expected in the second half of 2023. The data support the continued development of Vaxart’s oral norovirus vaccine candidate in adult populations. These data will inform dosage amounts for a bivalent norovirus Phase 2b study, the next step in progressing the vaccine candidate. The Phase 2b study is expected to add safety data that, if successful, will then enable Vaxart to schedule an End-of-Phase 2 meeting with the FDA, potentially in 2024.