Vaxart, Inc. (Nasdaq: VXRT) today announced positive topline data
from the dose-ranging Phase 2 clinical trial of its oral pill
bivalent norovirus vaccine candidate.
Preliminary results of the trial (NCT05626803)
showed robust serum immune responses across all doses at Day 29
relative to Day 1. Both doses showed a similar increase in serum
antibody responses with no statistical difference between the
medium and high dose arms. At Day 29, increases in serum IgA, IgG,
and BT50, for both the GII.4 and GI.1 strains in the vaccine arms,
were similar to those seen in previous norovirus studies conducted
by Vaxart. Mucosal and cell-based assay data will be available at a
later date.
Mean Fold Rise Summary (Day 1 to Day 29)
Preliminary Data
|
G1.1 |
GII.4 |
Serum antibodies |
IgA |
IgG |
BT50 |
IgA |
IgG |
BT50 |
Medium Dose (n=50) |
5.9 |
4.8 |
3.0 |
9.3 |
6.1 |
4.3 |
High Dose (n=59) |
6.4 |
4.2 |
2.3 |
8.6 |
5.1 |
7.8 |
Placebo (n=25) |
1.0 |
1.0 |
1.1 |
1.1* |
1.0 |
1.0* |
*excluding subject with confirmed gastroenteritis. |
|
Results from this Phase 2 dose-ranging study
also demonstrated that the bivalent norovirus vaccine candidate was
well tolerated, with a favorable safety profile that included no
vaccine-related serious adverse events (SAEs) and no dose limiting
toxicity. Adverse event rates for both doses were similar to
placebo.
“Topline data reported today further validate
the potential of our norovirus vaccine candidate and, more broadly,
our oral vaccine platform,” said Dr. James F. Cummings, Vaxart’s
Chief Medical Officer. “These data, additional forthcoming data
from this study, and the data we expect from our norovirus
challenge study will help inform our selection of dosage levels in
a larger Phase 2b study and support an End-of-Phase 2 meeting with
the U.S. Food and Drug Administration.
“Our bivalent vaccine is designed to target the
most important genogroups, GI and GII, and specifically to cover
the important strains, GI.1 and GII.4. GII.4 currently causes the
majority of norovirus disease in humans.”
The study enrolled 135 healthy adults at three
sites in the United States. The first 10 subjects received open
label high-dose vaccine and the remaining subjects were randomized
to high- or medium-dose vaccine (N=50 for each arm) or placebo
(N=25).
This is the seventh clinical trial completed in
Vaxart’s norovirus program, and it supports previous findings of
robust immunogenicity and benign tolerability. Collectively, the
data from these completed trials have shown immune responses from
Vaxart’s oral norovirus vaccine constructs to be strong,
long-lasting, and comparable to natural infection. Final results
could vary slightly from these preliminary data, and additional
timepoint measures and mucosal data from this study are expected in
the second half of 2023.
“The results take us one important step forward
in our clinical development,” said Andrei Floroiu, Vaxart’s Chief
Executive Officer. “Our norovirus vaccine candidates are the only
ones formulated for oral administration and optimized for delivery
to the gastrointestinal system, the site at which norovirus enters
the body. Today’s results add to the evidence supporting the
potential of this approach in addressing the unmet and critical
need for an approved norovirus vaccine.”
Vaxart’s Norovirus Program Next
Steps
The data reported today support the continued
development of Vaxart’s oral norovirus vaccine candidate in adult
populations and add to the growing body of evidence supporting its
clinical utility. These data, along with upcoming topline data from
the ongoing Phase 2 G1.1 challenge study, will inform dosage
amounts for a bivalent norovirus Phase 2b study, the next step in
progressing the vaccine candidate.
The Phase 2b study is expected to add safety
data that, if successful, will then enable Vaxart to schedule an
End-of-Phase 2 meeting with the U.S. Food and Drug Administration
(the “FDA”), potentially in 2024. Data from the Phase 2 study
announced today, along with a future Phase 3 study, are required
for a Biologics License Applications submission to the FDA as the
Company pursues a commercial pathway for its bivalent norovirus
candidate.
Norovirus is the leading cause of acute viral
gastroenteritis in all age groups in the U.S. There are no approved
vaccines for noroviruses. In the U.S. alone, the annual disease
burden from norovirus is $10.6 billion, as norovirus causes 19 to
21 million cases of acute gastroenteritis, (AGE), infecting 15% of
all children under the age of 5, and leads to 465,000 emergency
department visits, 109,000 hospitalizations, and 900 deaths on
average each year.
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 |
Vaxart (NASDAQ:VXRT)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
Vaxart (NASDAQ:VXRT)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024