CORRECTION - Zosano Pharma Announces Publication of Clinical Data Demonstrating Comparable Immunogenicity of a Trivalent Influenza Vaccine Formulated on its Transdermal Microneedle System Versus an Intramuscular Injection of the Vaccine at a Higher Dose
06 January 2022 - 4:01AM
In a press release published under the same headline today by
Zosano Pharma Corporation (Nasdaq:ZSAN), a measurement was
incorrectly stated as grams, not micrograms. The measurements of
the vaccine should have been 10μg and 15μg, not 10 g and 15 g as
previously stated. The corrected release follows:
Zosano Pharma Corporation (NASDAQ:ZSAN), a
clinical-stage biopharmaceutical company, today announced the
publication of Phase 1 clinical trial data in an article titled,
“Immunogenicity and Safety of Inactivated Influenza Split-Virion
Vaccine Administered via a Transdermal Microneedle System” in the
Journal of Vaccines and Immunology. The data demonstrated that a
low dose of a trivalent influenza vaccine administered via its
transdermal microneedle system produced antibody levels that met
EMEA’s three guidelines for influenza vaccine efficacy and was
generally well tolerated.
“We are excited to report these results, which show that a lower
dose of an influenza vaccine administered using our transdermal
microneedle system produced antibody levels similar to an
intramuscular injection of the same vaccine at a higher dose,” said
Mahmoud Ameri, Ph.D., vice president of research and development at
Zosano. “Notably, a number of diverse immune cells are present in
the skin, and therefore, we believe administration of a vaccine via
the outer layers of dermis has the potential to result in an
enhanced immune response.”
Dr. Ameri continued, “Additionally, there are several
disadvantages of intramuscular or subcutaneous injections,
including the necessity for medical personnel to administer the
vaccines, pain, and the risk of needlestick injury which is
estimated to cost $535 million per year globally to treat. With our
transdermal microneedle system, we have the potential to reduce
these burdens, as well as improve patient compliance. These data
further support the broad potential of our transdermal microneedle
system and highlight the need to modernize the drug delivery
technologies currently being used.”
The single-center, randomized Phase 1 study enrolled 90 subjects
between the ages of 18 to 40 years to receive a trivalent influenza
vaccine containing strains A/H1N1, A/H3N2, and B. Volunteers were
randomized to receive the vaccine either via a transdermal
microneedle system patch (10μg) worn for 5 minutes, the same patch
worn for 15 minutes, or by intramuscular injection (15μg). Antibody
levels were measured at Day 21 and compared to EMEA guidelines to
assess immunogenicity of the treatment groups. All three EMEA
criteria, including seroconversion rate, mean increase in
hemagglutinin inhibition titer, and percentage of seroprotected
subjects, were met for all three influenza strains in all treatment
groups. Additionally, on day 21, most study participants considered
microneedle patch application and removal to be less painful than
intramuscular injection, and most considered the patch to be their
first choice for mode of administration. The transdermal
microneedle patch was generally well tolerated.
About Zosano PharmaZosano Pharma Corporation is
a clinical-stage biopharmaceutical company focused on developing
products where rapid administration of approved molecules with
established safety and efficacy profiles may provide substantial
benefit to patients, in markets where patients remain underserved
by existing therapies. The company’s transdermal microneedle system
technology consists of titanium microneedles coated with drug that
are designed to enable rapid systemic administration of
therapeutics to patients. Zosano’s lead product candidate is M207,
which is a proprietary formulation of zolmitriptan designed to be
delivered via its transdermal microneedle system technology, as an
acute treatment for migraine. Learn more at
www.zosanopharma.com.
Forward-Looking StatementsThis press release
contains forward-looking statements. All statements other than
statements of historical facts contained herein are forward-looking
statements reflecting the current beliefs and expectations of
management made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995, including, but
not limited to, statements regarding the benefits and potential
uses of the company’s transdermal microneedle system, the potential
benefits and availability of M207 for patients, the potential
benefits and availability of an influenza vaccine administered via
the company’s transdermal microneedle system and other future
events and expectations described in this press release. Readers
are urged to consider statements that include the words “may,”
“will,” “would,” “could,” “should,” “might,” “believes,”
“estimates,” “projects,” “potential,” “expects,” “plans,”
“anticipates,” “intends,” “continues,” “forecast,” “designed,”
“scheduled,” “goal,” “approximately” or the negative of those words
or other comparable words to be uncertain and forward-looking.
These statements are subject to risks and uncertainties that are
difficult to predict, and actual outcomes may differ materially.
These include risks and uncertainties, without limitation,
associated with the company’s ability to obtain additional cash
resources to continue operations, the process of discovering,
developing and commercializing products that are safe and effective
for use as human therapeutics, risks inherent in the effort to
build a business around such products and other risks and
uncertainties described under the heading “Risk Factors” in the
company’s most recent annual report on Form 10-K and quarterly
reports on Form 10-Q. Although Zosano believes that the
expectations reflected in these forward-looking statements are
reasonable, Zosano cannot in any way guarantee that the future
results, level of activity, performance or events and circumstances
reflected in forward-looking statements will be achieved or occur.
All forward-looking statements are based on information currently
available to Zosano and Zosano assumes no obligation to update any
such forward-looking statements.
Zosano Contacts:Christine MatthewsChief
Financial Officer510-745-1200
Zosano PR:Sylvia Wheeler or Alexandra
Santosswheeler@wheelhouselsa.com or asantos@wheelhouselsa.com
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