Adamis Pharmaceuticals Submits Fast Track Application to FDA for Tempol for the Treatment and Prevention of COVID-19
10 Janeiro 2022 - 9:30AM
Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) today
announced the submission of a Fast Track Application to the U.S.
Food and Drug Administration (FDA) for Tempol for the treatment and
prevention of COVID-19. Tempol is currently being studied in a
Phase 2/3 clinical trial in adult patients with confirmed COVID-19
infection. Tempol has been shown to have antiviral,
anti-inflammatory, and antioxidant activity. Although recent oral
antiviral drugs have been approved by the FDA, the Company believes
that Tempol would provide an unmet medical need because of its
unique mechanism of action and safety profile.
Shyam Kottilil, MBBS, Ph.D., Professor of Medicine at the
University of Maryland School of Medicine (UMSOM), Chief of the
Division of Clinical Care and Research at UMSOM’s Institute of
Human Virology, and Principal Investigator for the ongoing Tempol
clinical trial, commented: “We are currently observing extremely
high COVID-19 infection rates and we urgently need additional safe
and effective oral agents. I am pleased with the conduct of the
ongoing clinical trial thus far. If positive effects are observed
and result from Tempol’s ongoing clinical trial, I believe that
this drug should be expedited through the approval process. Tempol
as an oral antiviral and anti-inflammatory agent may be an
important countermeasure, if proven safe and effective in this
trial.”
Dr. Dennis J. Carlo, President and Chief Executive Officer of
Adamis, commented, “Our ongoing clinical trial is continuing, as we
see a surge in COVID-19 infections in the U.S. and worldwide.
Concerns have been expressed about potential safety questions for
EUA approved antivirals such as mutagenesis and drug-drug
interactions (Molnupiravir: long-term safety questions linger as
approvals approach (pharmaceutical-technology.com))
(https://www.fda.gov/media/155050/download). We are thus applying
for Fast Track designation to the FDA to expedite the regulatory
approval pathway for Tempol. Because Tempol has both
anti-inflammatory and antiviral effects, we believe that Tempol
fulfills an unmet medical need as an oral agent, focusing on
multiple aspects of the pathogenesis of COVID-19 disease.”
Recently, researchers from the National Institutes of Health
(NIH) highlighted Tempol as a potential home antiviral treatment
for COVID-19
(https://covid19.nih.gov/news-and-stories/tempol-potential-home-treatment-covid-19).
The Company also recently announced
(https://ir.adamispharmaceuticals.com/news-releases/news-release-details/adamis-pharmaceuticals-announces-publication-human-immune)
the results of a published study in collaboration with Stanford
University researchers suggesting that Tempol has strong, broad
in-vitro anti-cytokine activity. Suppression of inflammatory
cytokines with an antioxidant may be a beneficial treatment
strategy in COVID-19 infection.
About the Phase 2/3 Clinical Trial
Additional information about the trial can be found on
www.clinicaltrials.gov using the identifier NCT04729595.
Adamis has licensed exclusive worldwide rights under patents,
patent applications and related know-how of the third part licensor
relating to Tempol for certain licensed fields including the
treatment of respiratory diseases including asthma, respiratory
syncytial virus, influenza and COVID-19, and for the reduction of
radiation-induced dermatitis in patients undergoing treatment for
cancer.
About Fast Track Designation
Fast Track is a process designed to facilitate the development,
and expedite the review, of drugs to treat serious conditions and
fill an unmet medical need. The purpose is to get important new
drugs to the patient earlier. Fast Track addresses a broad range of
serious conditions and the request can be initiated by the drug
company at any time during the development process. FDA will review
the request and decide based on whether the drug fills an unmet
medical need in a serious condition. Once a drug receives Fast
Track designation, early and frequent communication between the FDA
and the drug company is encouraged throughout the entire drug
development and review process.
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. The Company’s ZIMHI™ (naloxone)
Injection product is approved for the treatment of opioid overdose
(https://www.zimhi.com/). Tempol is in development for the
treatment of patients with COVID-19 and a Phase 2/3 clinical trial
is underway. For additional information about Adamis
Pharmaceuticals, please visit www.adamispharmaceuticals.com and
follow us on Twitter and LinkedIn.
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 opinions and beliefs of NIH researchers summarized
in the NIH article discussed in this press release concerning the
potential of Tempol as a treatment for COVID-19 and the results of
previous studies of Tempol; the Company’s beliefs concerning the
safety and effectiveness of Tempol or the Company’s other product
candidates; the timing, progress or results of the Company’s Phase
2/3 clinical trial for Tempol or other studies or trials relating
to Tempol; the Company’s beliefs concerning the outcome of its Fast
Track application to the FDA 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 rights and protection afforded by
patents and patent applications that it owns or has licensed; and
other statements concerning the Company’s 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 are
no assurances that the FDA will grant Fast Track designation for
the Company’s Tempol product candidate. There can be no assurances
regarding the timing, progress or outcome of trials or studies
relating to Tempol, 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 its US
Compounding Inc. subsidiary has 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 and any related governmental investigations or
proceedings. 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 DirectorICR
Westwicke619.228.5886robert.uhl@westwicke.com
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