Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) today
announced the initiation of patient dosing in the Phase 2/3
clinical trial for Tempol, an oral antiviral product candidate, in
adult patients with confirmed COVID-19 infection. In preclinical
studies, Tempol has been shown to have antiviral, anti-inflammatory
and antioxidant activity. The trial is designed to enroll 248
patients.
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 trial,
commented: “The timing for this trial could not be more important
as the delta variant spreads and breakthrough infections in
vaccinated individuals occur in the U.S. and worldwide. Tempol as
an oral antiviral and anti-inflammatory 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: “We are pleased to begin patient dosing in this
Phase 2/3 clinical trial for Tempol, which has demonstrated highly
encouraging preclinical data in several disease models of infection
and inflammation. Worldwide appearance of new variants with
increased transmissibility and resistance necessitates the
development of new therapeutic agents. The data from Israel should
be a wake-up call to the U.S. and the rest of the world. Israel has
among the highest levels of vaccination for COVID-19, yet the
country is now showing one of the world’s highest infection rates
(breakthrough). Currently, in Israel, the majority of the
hospitalized patients are fully gene vaccinated. If approved,
Tempol may not only prove to be a very important drug for the
treatment of COVID-19, but it may also play a role in curbing the
pandemic.”
Recently, the National Institutes of Health (NIH) highlighted
Tempol as a potential home treatment for COVID-19 (NIH Study) The
NIH news stated that, “This treatment would likely prevent severe
disease.” Recent studies conducted by NIH researchers suggested
that Tempol had potent antiviral activity against the virus that
causes COVID-19 in laboratory studies. The NIH news article further
describes how Tempol could possibly reduce COVID-19 symptoms by
calming inflammation, protecting organs from damage, and decreasing
the clumping of platelets.
The Company recently announced (Stanford Study) 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 early
COVID-19 infection.
About the Phase 2/3 Clinical Trial
This Phase 2/3 adaptive, randomized, double-blind,
placebo-controlled clinical trial is designed to enroll
approximately 248 high risk unvaccinated subjects with early
COVID-19 infection age 18 years of age and older. The primary
endpoint is the rate of hospitalization for patients receiving
Tempol, versus those receiving placebo. Eligible subjects with
positive COVID-19 infection within five days of study entry plus at
least one co-morbidity will be randomized 1:1 to receive either
Tempol or placebo. Co-morbidities include hypertension, diabetes,
obesity, cancer, chronic renal disease, and immunodeficiency, and
in the opinion of the investigator, the co-morbidity is not acutely
life threatening. Patients randomized to Tempol (n=124), will
receive 800mg daily in two divided doses of 400mg for up to 21
days. Similarly, placebo capsules will be administered twice daily
to subjects in the placebo group (n=124) for up to 21 days.
As part of the initial Phase 2 portion of the study, 50 COVID
positive subjects will be enrolled and randomized 1:1 to receive
either Tempol or placebo. An interim analysis by the data and
safety monitoring board (DSMB) will examine safety and markers of
systemic inflammation during a Stage 1 interim analysis. Based on
the DSMB analysis, the Phase 3 portion of the trial designed to
enroll 198 patients may begin, with a second interim analysis
planned after enrollment of 124 patients. A thorough safety
assessment will be conducted, and all treatment related adverse
events will be recorded, evaluated and compared for the treated and
placebo groups.
Adults who are interested in joining this study can visit
https://earlycovidstudy.com/.
Adamis licensed exclusive worldwide rights under patents, patent
applications and related know-how relating to Tempol for certain
licensed fields including the treatment of respiratory diseases
including asthma, respiratory syncytial virus infection, influenza
and COVID-19.
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 resubmitted New
Drug Applications (NDA) for its naloxone injection product
candidate, ZIMHI, for the treatment of opioid overdose, is
currently under FDA review. Tempol is in development for the
treatment of patients with COVID-19 and a Phase 2/3 clinical trial
is underway. Adamis is developing additional products, including
treatments for acute respiratory diseases, such as COVID-19,
influenza, asthma, and COPD. For additional information about
Adamis Pharmaceuticals, please visit
www.adamispharmaceuticals.com.
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 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;
funding for clinical trials relating to Tempol and the Company’s
ability to receive any government funding relating to clinical
development, studies or trials 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 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. There are no assurances that the Company will receive
any government funding relating to clinical investigations,
development or trials relating to Tempol or concerning the timing,
amount of, or terms and conditions relating to, any such
governmental funding that might be received. 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, as well as the
related internal 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
ICR 619.228.5886robert.uhl@westwicke.com
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