SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Vaxart, Inc., a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, announced today the initiation of a Phase 1 clinical trial of the first oral norovirus tablet vaccine.

“The start of the norovirus Phase 1 study is another important milestone for Vaxart’s oral vaccine platform,” said Wouter Latour, M.D., chief executive officer (CEO) of Vaxart. “We now have tablet vaccines in the clinic for norovirus, RSV and seasonal flu, three important pathogens with significant public health impact. A tablet vaccine for any of these indications would dramatically increase the efficiency of large vaccination campaigns - improving vaccine uptake and reducing costs. Having all three would be the ultimate trifecta in the vaccine sector.”

The randomized, double-blind, placebo-controlled Phase 1 dose-ranging study will assess the safety and immunogenicity of Vaxart’s VP1 protein-based norovirus tablet vaccine in 66 healthy adult volunteers. Study participants will be followed for 12 months for safety, and a broad range of systemic and local immune responses will be evaluated at multiple time points over the study.

“Norovirus is a significant public health concern, and there is increasing awareness of its medical burden and associated costs,” said Sean Tucker, Ph.D., founder and chief scientific officer (CSO) of Vaxart. “A tablet vaccine would be ideal for immunizing large populations, starting with the elderly and at-risk adults where norovirus causes considerable disease and mortality. Since our vaccine is expected to generate systemic and local immune responses in the gut as it is administered orally by tablet, we believe it is the optimal approach to protect against norovirus.”

About Norovirus

Norovirus is recognized as a leading cause of acute gastroenteritis. It is a common intestinal infection that typically lasts three to five days and is marked by watery diarrhea, vomiting, abdominal cramps, nausea and sometimes fever. Symptoms can be more severe in older adults and young children and may lead to serious complications including death. Norovirus causes frequent and widespread outbreaks in the military, food industry, travel industry, child care facilities, elderly homes and healthcare facilities.

According to estimates by the U.S. Centers for Disease Control and Prevention (CDC), norovirus causes 19 to 21 million illnesses in the United States each year, resulting in 56,000 to 71,000 hospitalizations and 570 to 800 deaths. In a recent John Hopkins University study by Lee et al., researchers estimated healthcare costs of norovirus at $4.2 billion and lost productivity costs at $56.2 billion globally.

Currently there are no norovirus vaccines approved by the U.S. Food and Drug Administration. For further information on norovirus, its burden on human health and vaccine development, please visit the websites of the CDC http://www.cdc.gov/norovirus/ and the Public Library of Science http://collections.plos.org/norovirus.

About Vaxart’s Oral Vaccine Platform

Vaxart’s oral vaccine platform enables delivery of recombinant vaccines using a convenient room temperature-stable tablet. Results of a Phase 1 study of the H1N1 seasonal influenza tablet vaccine, published in The Lancet Infectious Diseases, showed the oral vaccine generated broad immune responses in 92% of study participants.

About Vaxart

Vaxart is a clinical-stage company developing tablet vaccines based on its proprietary oral vaccine platform. Its lead development programs are oral tablet vaccines designed to protect against respiratory syncytial virus (RSV), norovirus and seasonal influenza. Vaxart vaccines are administered using convenient room temperature-stable tablets that can be stored and shipped without refrigeration, and eliminate the risk of needle-stick injury and medical waste associated with injectable vaccines. For more information, please visit www.vaxart.com.