Adamis Provides an Enrollment Update on the Phase 2/3 Study of Tempol in COVID-19 Positive High-Risk Subjects
September 12 2022 - 4:05PM
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced
that 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 has reached the initial planned enrollment of 248
subjects.
“We are very pleased to reach this trial milestone and eagerly
await the next DSMB meeting later this month,” David J. Marguglio,
Adamis’ CEO stated. “This interim meeting is significant as it will
mark the first time the DSMB evaluates statistical measures of
efficacy for Tempol.”
The Data Safety Monitoring Board (DSMB) is comprised of
infectious disease experts who independently review the unblinded
trial data and make recommendations. 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. 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 for approximately 190
subjects.
If analysis of the interim clinical data showed significant
efficacy, the DSMB may recommend stopping the trial because it has
already demonstrated statistical significance. If the interim data
indicated no efficacy on the primary endpoint, the DSMB would
likely recommend stopping the trial for futility. Under that
outcome, the Company would begin analyzing the then unblinded data
to determine if there were efficacy on the secondary endpoints. If
positive efficacy trends are observed on the primary endpoint in
favor of Tempol, but statistical significance is not reached, the
DSMB may recommend continuing the trial and enrolling additional
patients to further power the study.
Ron Moss, M.D., Chief Medical Officer of Adamis added, “If
either the interim data or the final clinical data shows positive
results, we would submit a clinical study report to the FDA and
request a meeting to discuss the findings and the potential for
Emergency Use Authorization. The Agency has approved two oral
antivirals under EUA for outpatients with COVID-19. Regardless of
what form COVID-19 takes going forward, we believe there will
always be a medical need and large market for new effective
therapeutics.”
About the Trial
“A Phase 2/3, Adaptive, Randomized, Double-Blind,
Placebo-Controlled Study to Examine the Effects of Tempol (MBM-02)
in Subjects With COVID-19 Infection” was designed to enroll
approximately 248 high risk subjects with early COVID-19 infection
age 18 years of age and older. 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 inflammatory
markers, hospitalizations, and all cause of mortality. Eligible
subjects with positive COVID-19 infection within five days of study
entry plus at least one co-morbidity were randomized one-to-one to
receive either Tempol or placebo. Co-morbidities include age of 65
or older, hypertension, diabetes, obesity, cancer, immunodeficiency
and in the opinion of the investigator the risk factor is not
acutely life-threatening. Patients randomized to Tempol received
800mg daily in two divided oral doses of 400mg capsules for up to
21 days. Similarly, placebo capsules were administered twice daily
to subjects in the placebo group for up to 21 days. Additional
information about the trial can be found on www.clinicaltrials.gov
using the identifier NCT04729595.
About Tempol
Tempol 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 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.
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, the availability of sufficient
funding, 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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