Vaxart Announces Initiation of Bivalent Norovirus Vaccine Phase 1b Clinical Trial
19 March 2019 - 10:00PM
Business Wire
- First Dosing with Norovirus GII.4 Oral Tablet
Vaccine Scheduled for Week of March 18 -
Vaxart, Inc., a clinical-stage biotechnology company developing
oral recombinant vaccines that are administered by tablet rather
than by injection, today announced the initiation of a Phase 1b
bivalent norovirus vaccine 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.
About Norovirus
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.
About Vaxart
Vaxart is a clinical-stage biotechnology company focused on
developing oral recombinant protein vaccines based on its
proprietary oral vaccine platform. Vaxart’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. Vaxart’s 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.
Vaxart’s 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). For more information, please visit
www.vaxart.com.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that
involve substantial risks and uncertainties. All statements, other
than statements of historical facts, included in this press release
regarding our strategy, prospects, plans and objectives, results
from preclinical and clinical trials, commercialization agreements
and licenses, beliefs and expectations of management are
forward-looking statements. These forward-looking statements may be
accompanied by such words as “believe,” “could,” “potential,”
“will” and other words and terms of similar meaning. Examples of
such statements include, but are not limited to, statements
relating to the Vaxart’s ability to develop and commercialize its
product candidates and clinical results and trial data; the
expected timing of the initiation of the Phase 1 bivalent study and
Phase 2 monovalent challenge study; and Vaxart’s expectations with
respect to the advantages it believes its oral vaccine platform can
offer over injectable alternatives, particularly for mucosal
pathogens such as norovirus, flu and RSV. Vaxart may not actually
achieve the plans, carry out the intentions or meet the
expectations or projections disclosed in our forward-looking
statements and you should not place undue reliance on these
forward-looking statements. Actual results or events could differ
materially from the plans, intentions, expectations and projections
disclosed in the forward-looking statements. Various factors could
cause actual results or events to differ materially from these
forward-looking statements, including Vaxart’s ability to raise
sufficient capital to fund the continued development of its product
candidates and complete its planned studies and trials, that
Vaxart’s product candidates may not be approved by the FDA or
non-U.S. regulatory authorities; that, even if approved by the FDA
or non-U.S. regulatory authorities, Vaxart’s product candidates may
not achieve broad market acceptance; that Vaxart may experience
manufacturing issues and delays; and other risks described in the
“Risk Factors” sections of Vaxart’s Quarterly and Annual Reports
filed with the SEC. Vaxart does not assume any obligation to update
any forward-looking statements, except as required by law.
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Carl MauchStern Investor
Relations212-362-1200vaxart@sternir.com
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