SOUTH
SAN FRANCISCO, Calif., Oct. 6, 2021
/PRNewswire/ -- Vaxart, Inc. (NASDAQ: VXRT) today
announced that it has begun recruiting
subjects for its Phase II COVID-19 oral
tablet vaccine clinical trial.
Vaxart expects to begin dosing the first
of 96 U.S. subjects, split evenly
between COVID-19 naïve and mRNA vaccinated subjects, later
this month.
The company's Phase II COVID-19 program will also
include countries outside of the United States, starting with a trial
in India that is expected to begin later this
year.
"Phase II is an extremely important milestone in the
development of the first and only COVID-19 oral tablet vaccine
that has reached this phase of development," said
Vaxart Chief Executive Officer, Andrei Floroiu.
"An oral vaccine has the potential to dramatically
impact the world's response to the
COVID-19 pandemic and to improve global public
health. It can be easier and faster to administer than injectables
and can help mitigate vaccine hesitancy, as many of those unwilling
to get vaccinated by needle would take an oral tablet vaccine,"
Floroiu said.
"We're very excited to start Phase II trials of
our S-only vaccine candidate because in our
nonhuman primate studies, our S-only vaccine
produced much higher serum antibody levels than
the S+N construct did," said Dr. Sean
Tucker, Vaxart's founder and Chief Scientific
Officer.
"Vaxart's new trials will generate key data that
will allow us to compare the S-only and S+N vaccine
candidates and help us decide on the
best development path forward for our COVID-19 vaccine
program, particularly in the face of emerging variant strains,"
added Dr. Tucker.
About Vaxart
Vaxart is a clinical-stage biotechnology
company developing a range of oral recombinant vaccines based on
its proprietary delivery platform. Vaxart vaccines are designed to
be administered using tablets that can be stored and shipped
without refrigeration and eliminate the risk of needle-stick
injury. Vaxart believes that its proprietary tablet vaccine
delivery platform is suitable to deliver recombinant vaccines,
positioning the company to develop oral versions of currently
marketed vaccines and to design recombinant vaccines for new
indications. Vaxart's development programs currently include tablet
vaccines designed to protect against coronavirus, norovirus,
seasonal influenza, and respiratory syncytial virus (RSV), as well
as a therapeutic vaccine for human papillomavirus (HPV), Vaxart's
first immune-oncology indication. Vaxart has filed broad domestic
and international patent applications covering its proprietary
technology and creations for oral vaccination using adenovirus and
TLR3 agonists.
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 Vaxart's strategy, prospects, plans and objectives,
results from pre-clinical and clinical trials, commercialization
agreements and licenses, and beliefs and expectations of management
are forward-looking statements. These forward-looking statements
may be accompanied by such words as "should," "believe," "could,"
"potential," "will," "expected," "plan," and other words and terms
of similar meaning. Examples of such statements include, but are
not limited to, statements relating to the receipt by Vaxart's
ability to develop and commercialize its product candidates,
including its vaccine booster products; Vaxart's expectations
regarding clinical results and trial data; and Vaxart's
expectations with respect to the effectiveness of its product
candidates. Vaxart may not actually achieve the plans, carry out
the intentions, or meet the expectations or projections disclosed
in the 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 important factors could cause actual results or
events to differ materially from the forward-looking statements
that Vaxart makes, including uncertainties inherent in research and
development, including the ability to meet anticipated clinical
endpoints, commencement, and/or completion dates for clinical
trials, regulatory submission dates, regulatory approval dates,
and/or launch dates, as well as the possibility of unfavorable new
clinical data and further analyses of existing clinical data; the
risk that clinical trial data are subject to differing
interpretations and assessments by regulatory authorities; whether
regulatory authorities will be satisfied with the design of and
results from the clinical studies; decisions by regulatory
authorities impacting labeling, manufacturing processes, and safety
that could affect the availability or commercial potential of any
product candidate, including the possibility 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 a Vaxart collaborator may not attain
development and commercial milestones; that Vaxart or its partners
may experience manufacturing issues and delays due to events
within, or outside of, Vaxart's or its partners' control;
difficulties in production, particularly in scaling up initial
production, including difficulties with production costs and
yields, quality control, including stability of the product
candidate and quality assurance testing, shortages of qualified
personnel or key raw materials, and compliance with strictly
enforced federal, state, and foreign regulations; that Vaxart may
not be able to obtain, maintain, and enforce necessary patent and
other intellectual property protection; that Vaxart's capital
resources may be inadequate; Vaxart's ability to resolve pending
legal matters; Vaxart's ability to obtain sufficient capital to
fund its operations on terms acceptable to Vaxart, if at all; the
impact of government healthcare proposals and policies; competitive
factors; 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
Vaxart Media
Relations:
|
Investor
Relations:
|
Mark Herr
|
|
Vaxart,
Inc.
|
|
mherr@vaxart.com
|
IR@Vaxart.com
|
(203)
517-8957
|
|
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SOURCE Vaxart, Inc.