Adamis Pharmaceuticals Announces IND Submission to FDA for Tempol for the Treatment of COVID-19
January 20 2021 - 9:00AM
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”)
announced today the submission of an Investigational New Drug (IND)
to FDA for the investigational use of Tempol for the treatment of
Coronavirus (COVID-19). The submission of the IND to FDA followed a
Pre-IND meeting with FDA in which FDA gave specific recommendations
on Chemistry, Manufacturing and Controls (CMC) and Clinical aspects
to be included in the IND. The Company plans to seek government
and/or non-government funding to study the treatment and prevention
of COVID-19 with Tempol.
Tempol has demonstrated both potent anti-inflammatory,
anticoagulant, and antioxidant activity. Both inflammatory
cytokines and reactive oxygen species (ROS) from cells of the
immune system called macrophages and neutrophils damage the lung in
Acute Respiratory Distress Syndrome (ARDS). In animal models,
Tempol has been shown to decrease proinflammatory cytokines
(cytokine storm), and through its potent antioxidant activity has
been shown to decrease the harmful effects of ROS. In addition,
Tempol has been shown to decrease platelet aggregation, a problem
observed in many COVID-19 patients. Numerous published articles
describing animal models of ARDS show Tempol to cause a decrease in
lung inflammation and preserve lung pathology associated with acute
and chronic lung injury. To this end, Tempol has been shown to
decrease the genes (HIF-la and HIF-2a) associated with hypoxia.
Hypoxia is a key indicator often associated with severe disease and
a poor outcome. Controlling hypoxia and the cytokine storm can be
considered essential to the successful treatment of COVID-19.
Dr. Dennis J. Carlo, President and CEO of Adamis commented:
“With over 23 million COVID-19 infections in the US and over
394,000 deaths in the US (according to the CDC), additional
treatments are urgently warranted. We believe that Tempol could
play a pivotal role not only in the treatment of COVID-19, but
actually in preventing hospitalization. With new mutations
occurring in the virus, it is apparent there is an ongoing need for
new therapies. The South African and other variants could very well
evade the protection of antibody treatments and also bring up
concerns about the efficacy of the current COVID-19 vaccines.
Mutations can possibly render these vaccines less potent and could
require them to be updated as with influenza vaccines.”
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. In
addition to its ZIMHI, naloxone injection product candidate, Adamis
is developing additional products, including treatments for acute
respiratory diseases, such as COVID-19, influenza, and asthma. The
company’s subsidiary, U.S. Compounding, Inc., 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.
Forward-Looking
StatementsThis 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
availability of, and the company’s success in applying for and
obtaining, government or other funding for studies or trials
relating to Tempol or the timing or amount of any such funding; the
results of any future 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; 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 our submission of the IND relating to
investigational use of, or trials or studies relating to, Tempol,
regarding the timing or the outcome of any applications or requests
that we may submit for government or other funding for studies or
trials relating to Tempol; concerning 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, forward-looking statements concerning our anticipated
future activities assume that we are able to obtain sufficient
funding to support such activities and continue our operations and
planned activities. As discussed in our filings with
the Securities and Exchange Commission, we will require
additional funding, and there are no assurances that such funding
will be available if required. 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, 2019 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. Except to the extent required by law,
any forward-looking statements in this press release speak only as
the date of this press release, and Adamis expressly disclaims any
obligation to update any forward-looking statements.
Contacts:Mark FlatherSenior Director, Investor
Relations& Corporate CommunicationsAdamis Pharmaceuticals
Corporation(858) 412-7951mflather@adamispharma.com
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