Business & Finance
Vaxart Completes Dosing of the Lead-In Cohort in Bivalent Norovirus Vaccine Phase 1b Clinical Trial
29 March 2019 - - US-based clinical-stage biotechnology company Vaxart, Inc has completed dosing of the lead-in cohort in the Phase 1b bivalent norovirus vaccine clinical trial with its oral norovirus GII.4 vaccine, the company said.

The Vaxart bivalent norovirus vaccine consists of an oral norovirus GI.1 vaccine and an oral norovirus GII.4 vaccine administered concurrently by tablet.

The bivalent norovirus Phase 1b trial consists of two parts, an open-label lead-in phase which has now been completed, and a randomised, double-blind, placebo-controlled phase which is expected to start in April, subject to final review by the FDA. Both portions of the trial are designed to evaluate safety and immunogenicity.

Vaxart said it expects to receive topline data from the trial in the second half of 2019.

Norovirus is recognized as a leading cause of acute gastroenteritis in the United States. It is a common intestinal infection that typically lasts three to five days and is marked by 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.

The US Centers for Disease Control and Prevention estimates that norovirus causes approximately 19 to 21m illnesses in the United States each year, resulting in 56,000 to 71,000 hospitalisations and 570 to 800 deaths, mostly among young children and older adults.

In a recent study by Johns Hopkins University and the CDC, researchers estimated the global economic impact of norovirus disease at USD 60bn, USD 34bn of which occurred in high income countries, including the United States, Europe and Japan.

Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant protein vaccines based on its proprietary oral vaccine platform.

The company's vaccines are designed to generate broad and durable immune responses that protect against a wide range of infectious diseases and may also be useful for the treatment of chronic viral infections and cancer.