Adamis Highlights National Institute of Health Study Identifying Tempol as a Potential Antiviral Drug for COVID-19
June 07 2021 - 7:30AM
Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) today highlighted
that the National Institutes of Health (NIH) has identified its
experimental drug, Tempol, as a potentially potent antiviral for
COVID-19. According to a study of cell cultures conducted by NIH
researchers, Tempol demonstrated an ability to limit SARS-CoV-2
infection by impairing the activity of a viral enzyme known as RNA
replicase. The NIH researchers also found that Tempol “doses used
in their antiviral studies could be likely achieved in tissues that
are the primary targets for the virus.”1
The June 3rd announcement issued by the NIH noted that the study
team was led by researchers from the Eunice Kennedy Shriver
National Institute of Child Health and Human Development. The team
also included researchers from the National Cancer Institute, the
National Institute of Allergy and Infectious Diseases and the
National Institute of Neurological Disorders and Stroke.
Additional study details disclosed include:
- Researchers discovered Tempol’s
effectiveness by assessing a basic question of how the virus
utilizes its RNA replicase, which is an enzyme that enables
SARS-CoV-2 to replicate its genome and make copies of itself when
inside a cell.
- Researchers tested if RNA replicase
and the enzyme’s nsp12 sub-unit require iron-sulfur clusters for
structural support.
- Findings indicate that the
SARS-CoV-2 RNA replicase requires two iron-sulfur clusters to
function optimally.
- Earlier studies mistakenly
identified these iron-sulfur cluster binding sites as zinc-binding
sites.
- Researchers found that Tempol can
degrade iron-sulfur clusters.
- Researchers intend to conduct
additional studies and will evaluate Tempol in a clinical study for
COVID-19.
Dr. Dennis J. Carlo, President and Chief Executive Officer of
Adamis, commented: “We are very pleased the NIH study has
demonstrated that Tempol – which has previously shown both
anti-inflammatory and anti-oxidant capability – is also a promising
potential antiviral treatment for COVID-19. The NIH results, along
with other data, suggest Tempol is well-suited for further study
for use in the early treatment of COVID-19.”
The NIH study follows studies conducted in collaboration with
Galveston National Laboratory and the University of Texas Medical
Branch at Galveston. These studies entailed hamsters being
challenged with SARS-CoV-2 receiving TEMPOL as a treatment. The
TEMPOL-treated animals showed decreased lung inflammation compared
to controls.
Earlier this year, Adamis announced that in-vitro inflammatory
cytokine data from a study done in collaboration with Stanford
University showed that TEMPOL significantly inhibited the release
of multiple inflammatory cytokines from activated immune cells of
COVID-19 patients. The Stanford study suggested Tempol may prevent
the cytokine storm observed in COVID-19 patents.
The Company believes that the results from the NIH study also
support the design and implementation of the protocol in Adamis’
Investigational New Drug Application to study Tempol in early
COVID-19 infection. The goal of this study titled, “A Phase 2/3,
Adaptive, Randomized, Double-Blind, Placebo-Controlled Study to
Examine the Effects of Tempol (MBM-02) on Preventing COVID-19
Related Hospitalization in Subjects with COVID-19 Infection,” is to
examine the safety and activity of Tempol in COVID-19 patients
early in the infection. In addition to safety, the study will
examine markers of inflammation, COVID-19 symptoms, and the rate of
hospitalization for patients taking Tempol versus placebo early in
COVID-19 infection. More details of the protocol can be found here
or by searching www.clinicaltrials.gov and using the identifier
NCT04729595.
Adamis has previously licensed exclusive worldwide rights under
patents, patent applications and related know-how to use Tempol for
the treatment of respiratory diseases including asthma, respiratory
syncytial virus, influenza and COVID-19, as well as the use of
Tempol as a therapeutic for reducing radiation-induced dermatitis
in patients undergoing treatment for cancer.
About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a specialty
biopharmaceutical company primarily focused on developing and
commercializing products in various therapeutic areas, including
allergy, opioid overdose, respiratory and inflammatory disease. The
Company’s SYMJEPI (epinephrine) Injection products are approved by
the FDA for use in the emergency treatment of acute allergic
reactions, including anaphylaxis. Adamis’ naloxone injection
product candidate, ZIMHI, for the treatment of opioid overdose is
currently under FDA review. Adamis is developing additional
products, including treatments for acute respiratory diseases, such
as COVID-19, influenza, asthma, and COPD. The company’s subsidiary,
US Compounding Inc. (USC), compounds sterile prescription
drugs, and certain nonsterile drugs for human and veterinary use by
hospitals, clinics, surgery centers, and vet clinics throughout
most of the United States. For additional information about Adamis
Pharmaceuticals, please visit www.adamispharmaceuticals.com.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Such forward-looking statements include those that express
plans, anticipation, intent, contingencies, goals, targets or
future development and/or otherwise are not statements of
historical fact. These statements relate to future events or future
results of operations, including, but not limited to the following
statements: the Company’s beliefs concerning the safety and
effectiveness of Tempol or the Company’s other product candidates;
the timing of funding for, or commencement or completion of, any
studies or trials relating to Tempol; the results of any studies or
trials that the Company may conduct relating to Tempol; the
Company’s ability to commercialize the product candidates described
in this press release, itself or through commercialization
partners; the Company’s beliefs concerning the benefits,
enforceability, and extent of intellectual property protection
afforded by patents and patent applications that it owns or has
licensed, and its ability to enforce its patents and other
intellectual property rights against third parties; and other
statements concerning our future operations and activities. These
statements are only predictions and involve known and unknown
risks, uncertainties, and other factors, which may cause Adamis'
actual results to be materially different from the results
anticipated by such forward-looking statements. There can be no
assurances regarding the outcome of trials or studies relating to,
Tempol; the timing or outcome of any such studies or trials; or
that Tempol will be found to be safe and effective in the treatment
of COVID-19 or any other indication. In addition, as previously
disclosed, each of the Company and USC recently received a subpoena
from the U.S. Attorney’s Office for the Southern District of New
York issued in connection with a criminal investigation.
Accordingly, all forward-looking statements are subject to the
outcome of this investigation, as well as the related investigation
being conducted by the Company’s Audit Committee. We cannot assess
the impact of each factor on our business or the extent to which
any factor, or combination of factors, may cause actual results to
differ materially from those contained in any forward-looking
statements. You should not place undue reliance on any
forward-looking statements. Further, any forward-looking statement
speaks only as of the date on which it is made, and except as may
be required by applicable law, we undertake no obligation to update
or release publicly the results of any revisions to these
forward-looking statements or to reflect events or circumstances
arising after the date of this press release. Certain of these
risks and additional risks, uncertainties, and other factors are
described in greater detail in Adamis’ filings from time to time
with the SEC, including its annual report on Form 10-K for the
year ended December 31, 2020 and subsequent filings with
the SEC, which Adamis strongly urges you to read and consider,
all of which are available free of charge on
the SEC's web site at http://www.sec.gov.
Contact:
Adamis Investor RelationsRobert UhlManaging DirectorWestwicke
ICR619.228.5886robert.uhl@westwicke.com
1 National Institutes of Health, “NIH researchers identify
potential new antiviral drug for COVID-19,” June 3, 2021.
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