– First Dosing with Norovirus GII.4 Oral Tablet Vaccine Scheduled for
Week of March 18 –
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, 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.
Contacts
Carl Mauch
Stern Investor Relations
212-362-1200
vaxart@sternir.com