Adamis Provides Update on Clinical Trial Start-Up Progress for Tempol in the Treatment of COVID-19
June 11 2021 - 7:30AM
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today
announced that clinical trial start-up activities are underway for
examining the effects of Tempol, which is the Company’s
experimental drug, in the treatment of COVID-19. Adamis is carrying
out these activities with a large clinical research organization
(CRO).
Commenced activities include site identification and initiation,
data base production, vendor management, and the establishment of
an independent data safety monitoring board of infectious disease
experts, who will review the safety and efficacy of the trial.
Clinical trial drug product and placebo have also been
obtained.
The goal of the trial — entitled “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, symptoms, and the rate of
hospitalization for patients taking Tempol versus placebo.
Additional information about the trial can be found on
www.clinicaltrials.gov using the identifier NCT04729595.
The clinical trial start-up activities follow recently published
work by the National Institutes of Health (NIH), which has
identified Tempol as a potentially potent antiviral for COVID-19.
As previously reported, in 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. Tempol produced a 5 log decrease in virus levels in
cells infected with SARS-CoV-2. Notably, as a single agent, Tempol
performed better in inhibiting RNA replicase than Remdesivir®,
which has been approved on an emergency use basis for the treatment
of COVID-19. Tempol also synergized with Remdesivir®.
Dr. Dennis Carlo, Chief Executive Officer of Adamis, commented
on the start-up activities of the clinical trial: “We believe that
additional treatment modalities are sorely-needed for COVID-19 due
to the surge of virus variants. Because of Tempol’s mechanism of
action, it may inhibit viral replication of all current and future
variants of the virus. The results of the NIH studies further
support the importance of our clinical trial. The addition of a
well-respected data safety monitoring board to the well-designed
trial should further increase the likelihood of meaningful clinical
data. We look forward to carrying out this trial and helping
produce another potential breakthrough treatment for COVID-19.”
Adamis has a worldwide license to use Tempol for the treatment
of respiratory diseases including asthma, respiratory syncytial
virus, influenza and COVID-19.
For additional information on Tempol and its potential use as a
treatment for COVID-19, see the presentation by Dr. Ronald Moss,
Chief Medical Officer of Adamis, to the European Society of
Medicine “Novel effects of Tempol for the treatment of COVID19”
(https://www.youtube.com/watch?v=F1Pd4qG-MbY).
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
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