Vaxart, Inc., a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, today announced it has started dosing subjects in the randomized cohort of the Phase 1b bivalent norovirus vaccine clinical trial.
We are delighted to start the randomized portion of the bivalent norovirus phase 1b trial, said David Taylor, M.D., chief medical officer of Vaxart. The monovalent GII.4 vaccine tablets performed as expected in the lead-in cohort we just completed, and we look forward to building on the excellent results we observed previously with our monovalent GI.1 vaccine. Norovirus is the leading cause of foodborne illness in the United States and causes significant morbidity and mortality in older adults and the very young. Our oral norovirus vaccine could provide a significant public health benefit for these vulnerable populations in the United States and beyond.
The Vaxart bivalent norovirus vaccine consists of an oral norovirus GI.1 vaccine tablet and an oral norovirus GII.4 vaccine tablet administered concurrently. The bivalent norovirus Phase 1b trial includes two stages, an open-label lead-in phase which was completed successfully earlier this month, and a randomized, double-blind, placebo-controlled phase which has now started. Both portions of the trial are designed to evaluate safety and immunogenicity. The Company expects to receive topline data from the trial 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.
Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant protein vaccines based on its proprietary oral vaccine platform. Vaxarts 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. Vaxarts vaccines are administered using a convenient room temperature-stable tablet, rather than by injection. Vaxart believes that tableted vaccines are easier to distribute and administer than injectable vaccines and have the potential to significantly increase vaccination rates. Vaxarts development programs include oral tablet vaccines that are designed to protect against norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV).
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