Adamis Provides Update on the Phase 2/3 Trial of Tempol in COVID-19 Positive High-Risk Subjects
September 21 2022 - 7:30AM
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced
that the third planned interim analysis of the Phase 2/3 clinical
trial examining the effects of Tempol in high risk subjects with
early COVID-19 infection did not achieve its primary endpoint, as
measured by comparing the rate of sustained clinical resolution of
symptoms of COVID-19 at day 14 of Tempol versus placebo. The
independent Data Safety Monitoring Board (DSMB) recommended that
the study be halted early due to lack of efficacy. The DSMB did
note that no safety concerns were identified in the subjects that
received Tempol. Based on the recommendation from the DSMB, the
Company has halted the trial and will now evaluate the unblinded
data from the trial to determine the next developmental steps for
Tempol.
“We are obviously disappointed that the study did not meet its
endpoints,” said Ron Moss, MD, Chief Medical Officer of Adamis.
“Much of the preclinical work on Tempol for COVID-19 examined the
effects of the drug on severe illness. This trial did not meet its
primary endpoint, but we are exploring the possibility that
vaccinations and the less virulent variants (Omicron) during the
trial period may have obscured an effect of Tempol. This
speculation is based on the lower-than-expected observed
hospitalization rate in this trial (less than 1%) compared to other
COVID-19 treatment trials. We will continue to analyze the data to
determine if we believe Tempol can be utilized in other COVID
patient populations including those with more severe illness or
immunocompromised. I would like to thank our clinical research
partners, the trial investigators and all the trial subjects for
their participation.”
David J. Marguglio, Adamis’ CEO added, “Though we are certainly
frustrated with these results, we remain bullish on ZIMHI®
(launched in 2022) and SYMJEPI® and our team is focused on
increasing sales and improving manufacturing efficiencies for our
commercial products.”
Phase 2/3 Trial
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. 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.
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 has been conducted. 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 statements
concerning the following matters: the next developmental steps for
Tempol; possible factors affecting the results of the Phase 2/3
clinical trial for Tempol; possible use of Tempol in other COVID
patients including those with more severe illness; the Company’s
beliefs concerning the mechanisms of action, safety and
effectiveness of Tempol; the Company's beliefs concerning the
ability of its products and product candidates to compete
successfully in the market; and the Company’s believes concerning
improvement of manufacturing efficiencies for its commercial
products. 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 next developmental steps for Tempol;
that vaccinations or less virulent variants of COVID-19 during the
trial period affected the results of the Phase 2/3 clinical trial;
that the Company will explore the use of Tempol with other
categories of COVID patients; or that sales of the Company’s
commercial products will increase or that manufacturing
efficiencies will be achieved. 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. 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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