Adamis Pharmaceuticals Provides Update on Clinical Study Assessing Tempol for the Treatment of COVID-19
July 29 2022 - 6:30AM
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today provided an
update on the Company’s ongoing U.S. Phase 2/3 clinical trial to
evaluate the safety and efficacy of Tempol as a treatment for
COVID-19. The next Data Safety Monitoring Board (DSMB) meeting to
review interim data results has been scheduled for late September.
The DSMB previously met to evaluate the clinical and safety data
from interim analyses in March and June 2022, and both times
recommended that the study continue without modification.
The DSMB is comprised of infectious disease experts who
independently review the unblinded trial data and make
recommendations. The Company will not have access to unblinded
trial data until the trial has concluded. At the September meeting,
the DSMB plans to evaluate the primary efficacy endpoint, the
sustained resolution of COVID-19 symptoms, as well as safety in
individuals who are at high risk for disease progression. If the
DSMB recommendations indicate that the analysis of the clinical and
safety data from the trial demonstrates significant efficacy,
Adamis would submit a clinical study report to the FDA and request
a meeting to discuss the findings and next steps for continued
clinical development. If positive trends are observed in favor of
the Tempol treatment group, the DSMB may recommend continuing the
study along with the enrollment of additional subjects. If no
efficacy is demonstrated, then the Company would likely stop the
trial.
“We are committed to continue advancing Tempol for the treatment
of COVID-19, especially with the recent increase of cases due to
new variants,” said David J. Marguglio, President and Chief
Executive Officer of Adamis Pharmaceuticals. “With more than 200
patients enrolled, we believe this next DSMB data review could
provide important additional insights into the safety and treatment
effects of Tempol, as well as the future clinical path for
Tempol.”
About the Trial
Tempol is being evaluated in an ongoing Phase 2/3, adaptive,
randomized, double-blind, placebo-controlled study to examine the
effects of Tempol in subjects with mild to moderate COVID-19
infection. The primary endpoint is the rate of sustained clinical
resolution between Tempol and the standard of care versus placebo
and the standard of care at Day 14. In addition to the primary
endpoint, a number of secondary endpoints will be reviewed
including, but not limited to, changes in cytokines and
inflammatory markers, hospitalizations, and all cause of mortality.
Additional information about the trial can be found on
www.clinicaltrials.gov using the identifier NCT04729595.
About Tempol
Tempol (APC100) is a redox cycling nitroxide that promotes the
metabolism of many reactive oxygen species and improves nitric
oxide bioavailability. It has been studied extensively in animal
models of oxidative stress and inflammation. Preclinical studies of
Tempol have shown it to have antiviral, anti-inflammatory, and
antioxidant activity. Adamis has licensed exclusive rights under
certain patents, patent applications and related know-how relating
to Tempol for certain licensed fields including the fields of
COVID-19 infection, asthma, respiratory syncytial virus infection,
and influenza infection, as well as a therapeutic for
radiation-induced dermatitis. The Phase 2/3 clinical trial
examining the safety and efficacy of Tempol in COVID-19 patients
early in the infection began in September 2021.
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. 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 our website 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: statements concerning the Company’s Phase 2/3 clinical
trial for Tempol; statements concerning the activities and process
of the DSMB and the timing and outcome of that process; the
Company’s beliefs concerning the mechanisms of action, safety and
effectiveness of Tempol and that Tempol addresses an unmet medical
need; 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 ability of its
products and product candidates to compete successfully in the
market; 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, including those relating to Tempol; the Company’s
ability to successfully commercialize the products and product
candidates, itself or through commercialization partners; 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 concerning the timing or outcome of, or
recommendations resulting from, any future meeting of the DSMB.
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, forward-looking statements
concerning our anticipated future activities assume that we have
sufficient funding to support such activities and continue our
operations and planned activities. Statements in this press release
concerning future events depend on several factors beyond the
Company's control, including the absence of unexpected developments
or delays, market conditions, and the regulatory approval process.
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, 2021, 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 website at http://www.sec.gov.
Contacts
Adamis Investor RelationsRobert UhlManaging
DirectorICR Westwicke619.228.5886robert.uhl@westwicke.com
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