Vaxart Completes Enrollment in Phase 1 Trial for its Norovirus Oral Pill Vaccine Candidate
Vaxart, Inc. recently announced it completed enrollment of its Phase 1 clinical trial evaluating its second-generation oral norovirus vaccine constructs head-to-head against its first-generation constructs.
“Completing enrollment in this trial bring us one step closer in our development of a norovirus vaccine, where there is a significant unmet need,” said Steven Lo, Chief Executive Officer of Vaxart. “We are excited about the potential of our second-generation oral norovirus vaccine constructs that we believe may be more potent than our first-generation constructs. We look forward to sharing the topline data in 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. Norovirus is a leading cause of acute gastroenteritis worldwide, and Vaxart’s oral vaccine candidate aims to provide a convenient and effective solution for this significant public health challenge.
An independent Data and Safety Monitoring Board (DSMB) conducted a pre-planned interim safety data review and recommended the study to continue without any modifications.
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 US FDA. A Phase 3 trial could then begin as early as 2026.
Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using pills that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary pill vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Vaxart’s development programs currently include pill vaccines designed to protect against coronavirus, norovirus and influenza, as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immune-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.
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