Altimmune Reports Data from its Phase 1b Clinical Trial of NasoShield™
April 01 2021 - 7:00AM
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical
company, reported clinical data today on its NasoShield intranasal
anthrax vaccine candidate. The Phase 1b trial evaluated the safety
and immunogenicity of one and two-dose regimens of NasoShield in
healthy volunteers. The clinical trial was conducted with support
from the Biomedical Advanced Research and Development Authority
(BARDA).
The trial enrolled 42 healthy subjects who
received intranasally administered NasoShield or saline placebo and
were then monitored for 6 months post-dosing. The primary endpoint
was the safety and tolerability of NasoShield. The primary
immunogenicity readouts included the serum binding antibody to
protective antigen and anthrax toxin blocking antibody responses at
28- and 56-days post-dose administration. Stimulation of the
mucosal IgA immune response in the nasal cavity was also
assessed.
The clinical data from the Phase 1b trial showed
that:
- Serum binding antibody responses to
the protective antigen of Bacillus anthracis, the bacterium and
causative agent of anthrax, were significantly greater than in the
placebo arm.
- Antibody responses blocking anthrax
toxin were blunted compared to protective antigen antibody
responses and were low compared to prior studies conducted with
BioThrax®, the only approved anthrax vaccine.
- Notably, as with Altimmune’s other
intranasally administered replication-deficient adenovirus
vaccines, nasal mucosal IgA responses specific for protective
antigen were observed in up to 80% of subjects
post-vaccination.
- The safety and tolerability of
NasoShield was excellent and comparable to intranasal saline
placebo in both the number and characteristics of adverse or
reactogenicity events, consistent with other clinical trials of
Altimmune’s intranasal vaccine candidates.
The NasoShield program is funded through a
contract (HHSO100201600008C) with BARDA which, if all options are
exercised, is expected to provide funding through the end of Phase
2 development. The Company plans to conduct a comprehensive review
of the data with BARDA to determine the path for continued
development of the program.
About NasoShieldIn contrast to
the currently licensed vaccine that requires three injected doses
of vaccine over one month for protection, NasoShield is being
developed as a single-dose, intranasal anthrax vaccine. The
NasoShield product characteristics may also provide for greatly
improved logistics in distribution and administration allowing it
to be used more effectively than the currently approved vaccine in
the event of an anthrax incident.
About AltimmuneAltimmune is a
clinical stage biopharmaceutical company focused on developing
intranasal vaccines, immune modulating therapies and treatments for
liver disease. Our diverse pipeline includes proprietary intranasal
vaccines for COVID-19 (AdCOVID™), anthrax (NasoShield™) and
influenza (NasoVAX™); an intranasal immune modulating therapeutic
for COVID-19 (T-COVID™); and next generation peptide therapeutics
for NASH (ALT-801) and chronic hepatitis B (HepTcell™).
For more information on Altimmune, please
visit www.altimmune.com.
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Forward-Looking Statement for
AltimmuneAny statements made in this press release
relating to future financial or business performance, conditions,
plans, prospects, trends, or strategies and other financial and
business matters, including without limitation, the potential for
additional funding from BARDA, the potential immunization effects
of NasoShield, and the prospects for regulatory approval,
commercializing or selling any product or drug candidates, are
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. In addition, when or if
used in this press release, the words “may,” “could,” “should,”
“anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,”
“predict” and similar expressions and their variants, as they
relate to Altimmune, Inc. (the “Company”) may identify
forward-looking statements. The Company cautions that these
forward-looking statements are subject to numerous assumptions,
risks, and uncertainties, which change over time. Important factors
that may cause actual results to differ materially from the results
discussed in the forward looking statements or historical
experience include risks and uncertainties, including risks
relating to: potential impacts due to the COVID-19 pandemic such as
delays in regulatory review, manufacturing and supply chain
interruptions, access to clinical sites, enrollment, adverse
effects on healthcare systems and disruption of the global economy
the reliability of the results of studies relating to human safety
and possible adverse effects resulting from the administration of
the Company’s product candidates; funding delays, reductions in or
elimination of U.S. government funding and/or non-renewal
of expiring funding under the Company’s agreement with BARDA; and
the Company’s ability to satisfy certain technical milestones under
the Company’s contracts with BARDA that would entitle the Company
to receive additional funding over the period of the agreement.
Further information on the factors and risks that could affect the
Company's business, financial conditions and results of operations
are contained in the Company’s filings with the U.S.
Securities and Exchange Commission, including under the heading
“Risk Factors” in the Company’s annual report on Form 10-K for the
fiscal year ended December 31, 2020 filed with
the SEC, which is available at www.sec.gov.
Altimmune Investor & Media Contacts:
Will
Brown |
Stacey
Jurchison |
Chief Financial Officer |
Sr. Dir, Investor Relations |
Phone: 240-654-1450 |
Phone : 410-474-8200 |
wbrown@altimmune.com |
sjurchison@altimmune.com |
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