Vaxart Announces Last Subject Dosed in Phase 2 Trial of its Bivalent Norovirus Candidate, and All Subjects Challenged in Phase 2 Challenge Study of Monovalent Norovirus Candidate
June 06 2023 - 7:00AM
Vaxart, Inc. (Nasdaq: VXRT) today announced that the last subject
has completed dosing in the Phase 2 clinical trial of its oral pill
bivalent norovirus vaccine candidate. In addition, all patients
have been challenged in its challenge study of its G.1.1 monovalent
vaccine candidate. No vaccine related SAEs have been reported to
date in either trial, consistent with the safety profile observed
in all our norovirus trials.
“We look forward to announcing key topline data
of both Phase 2 trials for our norovirus candidates in the coming
months as we continue to make timely progress in these studies,"
said Dr. James F. Cummings, Vaxart’s Chief Medical Officer. “Both
trials now are fully enrolled, and all subjects have been dosed and
no vaccine-related SAEs reported in either study. Data from these
Phase 2 trials will inform the next steps for our clinical
development strategy for these potentially promising vaccine
candidates.”
Vaxart continues to expect to report topline
data from the ongoing Phase 2 dose-ranging study (NCT05626803) of
its bivalent norovirus vaccine candidate in mid-2023. The primary
endpoints are safety and immunogenicity, with the objective of
determining dose levels for Phase 3 development.
The Company also expects to report topline data
from the ongoing Phase 2 challenge study (NCT05212168) of Vaxart’s
G1.1 monovalent norovirus vaccine candidate during Q3 2023. Primary
endpoints include safety and reduction in acute gastroenteritis
(AGE) caused by norovirus infection, while additional endpoints
include reduction in AGE severity, reduction in shedding, and
immunogenicity, with the objective of determining efficacy against
norovirus G1.1-induced AGE.
Norovirus is the leading cause of acute viral
gastroenteritis in all age groups in the U.S. However, there are no
approved vaccines for noroviruses. In the U.S. alone, the annual
disease burden from norovirus is $10.5 billion, as on average
norovirus causes 19 to 21 million cases of AGE, infects 15% of all
children under the age of 5, and leads to 465,000 emergency
department visits, 109,000 hospitalizations, and 900 deaths.
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 pills that
can be stored and shipped without refrigeration and eliminate the
risk of needle-stick injury. Vaxart believes that its proprietary
pill 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
pill vaccines designed to protect against norovirus, coronavirus,
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 preclinical and clinical trials and
the timing of such results, 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," “anticipate,” "plan," and other
words and terms of similar meaning. Examples of such statements
include, but are not limited to, statements relating to 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 the timing of
receiving and reporting such 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: |
Mark Herr |
Vaxart, Inc. |
mherr@vaxart.com |
(203) 517-8957 |
Investor
Relations: |
Andrew Blazier |
FINN Partners |
IR@vaxart.com |
(646) 871-8486 |
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