"We are pleased to receive BARDA approval to move forward with dosing in this large-scale study and expect to dose the first patient in this cohort in the second quarter of 2025," said Steven Lo, Chief Executive Officer of Vaxart. "We are deeply grateful for the continued support of our government partners at HHS and BARDA, whose collaboration is critical to advancing our clinical development program." The Phase 2b trial is a double-blind, multi-center, randomized, comparator-controlled study. It is designe ...

Company Overview - Vaxart, Inc. is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform [6] - The company aims to provide vaccines that can be administered in pill form, eliminating the need for refrigeration and reducing the risk of needle-stick injuries [6] Clinical Trial Progress - Vaxart has completed enrollment for its Phase 1 clinical trial of its second-generation oral norovirus vaccine constructs, which are being evaluated against first-generation constructs [2][3] - The Phase 1 trial is designed to assess safety and immune responses correlated with protection from norovirus, a leading cause of acute gastroenteritis globally [3] Future Development Plans - If the Phase 1 trial is successful, Vaxart plans to initiate a Phase 2 safety and immunogenicity study potentially starting in the second half of 2025, followed by an End of Phase 2 meeting with the FDA [5] - A Phase 3 trial could commence as early as 2026, contingent on successful outcomes and potential partnerships or funding [5] Safety Review - An independent Data and Safety Monitoring Board (DSMB) conducted an interim safety review and recommended that the study continue without modifications [4] Market Need - The development of Vaxart's oral norovirus vaccine is driven by a significant unmet public health need, as norovirus is a major cause of gastroenteritis worldwide [3]