The bivalent Norovirus GII.4 oral tablet vaccine developed by Vaxart is moving forward–the initiation of a Phase 1b clinical trial.
“The initiation of the bivalent norovirus vaccine Phase 1b trial marks a significant step towards our goal of developing a vaccine that can protect the most vulnerable patients from this highly infectious disease,” said Wouter Latour, M.D., chief executive officer of Vaxart. “Norovirus infection disproportionately affects the elderly and the very young, and we believe an oral vaccine would be the optimal approach to prevent the significant morbidity and even mortality in these age groups.”
The bivalent norovirus vaccine Phase 1b trial consists of two parts, an open-label lead-in phase during which 6 subjects will be dosed with norovirus GII.4 vaccine, and a double-blind, placebo-controlled phase during which a total of 80 subjects will be randomized into four groups and dosed with either placebo, norovirus GI.1 vaccine, norovirus GII.4 vaccine or both norovirus vaccines. Both portions of the study are designed to evaluate safety and immunogenicity. Vaxart expects the first dosing of the randomized portion of the study to begin in April, subject to final review by the FDA. The Company expects to receive topline data from the Phase 1b clinical study in the second half of 2019.
In addition, the Company reported it remains on track to initiate the Phase 2 monovalent norovirus challenge study in the second quarter of 2019, with results expected in the second half of 2019.
Norovirus is recognized as the 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 U.S. Centers for Disease Control and Prevention (CDC) estimates that norovirus causes approximately 19 to 21 million illnesses in the United States each year, resulting in 56,000 to 71,000 hospitalizations 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 global economic impact of norovirus disease at $60 billion, $34 billion of which occurred in high income countries, including the United States, Europe and Japan.
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