Adamis Pharmaceuticals Provides Update on Clinical Study Assessing Tempol for the Treatment of COVID-19
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) announced that the Data Safety Monitoring Board (DSMB) has reviewed the interim clinical and safety data for its Phase 2/3 clinical trial of Tempol for treating COVID-19 and has recommended that the study proceed as planned. The DSMB's assessment indicates a favorable evaluation of the trial data. CEO David J. Marguglio emphasized the importance of completing the trial amid ongoing public health challenges with COVID-19. Previous studies showed Tempol's significant anti-cytokine activity and inflammation reduction in animal models.
- DSMB recommended continuing the Phase 2/3 clinical trial, indicating favorable interim safety and efficacy data.
- Previous studies demonstrate Tempol's strong anti-cytokine activity and reduced lung inflammation in animal models.
- None.
DSMB Has Reviewed Interim Clinical and Safety Data and Recommended that the Study Continue
SAN DIEGO, June 01, 2022 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a biopharmaceutical company developing and commercializing specialty products for allergy, opioid overdose, respiratory and inflammatory diseases, today announced that a meeting of the Data Safety Monitoring Board (DSMB) overseeing the Company’s Phase 2/3 clinical trial investigating the use of Tempol for the treatment of COVID-19, was held on May 31 to evaluate interim clinical and safety data for the trial. The DSMB is composed of subject matter experts and can unblind the data to determine the treatment effects of the subjects in the trial. Based on an interim review of the data, the DSMB determined that the study can continue as planned.
“We look forward to the completion and final analysis of this important clinical trial,” said David J. Marguglio, Chief Executive Officer of Adamis Pharmaceuticals. “We appreciate the timely feedback from the DSMB as COVID-19 remains a serious public health problem with recent spikes in infections due to omicron and other variants. Additional therapeutic options are needed for outpatient treatment of COVID-19.”
The Company previously announced the results of a published study in collaboration with Stanford University researchers, suggesting that Tempol has strong, broad in-vitro anti-cytokine activity. In addition, the Company previously announced that in an animal SARS-COV2 challenge model, a decrease in inflammation was noted in the lungs of animals given Tempol compared to control animals.
About the Tempol Phase 2/3 Trial
Additional information about the trial can be found on www.clinicaltrials.gov using the identifier NCT04729595. Adamis has licensed exclusive worldwide rights under certain 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, influenza and COVID-19, and for the reduction of radiation-induced dermatitis in patients undergoing treatment for cancer.
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.
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; the Company’s ability to enter into new collaborations and partnerships and create long-term value for patients, providers and stockholders; 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 amount of time that the DSMB will take to conduct or complete any future analyses or reviews or concerning the results or outcome of that analysis. 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 web site at http://www.sec.gov.
Contacts
Adamis Investor Relations
Robert Uhl
Managing Director
ICR Westwicke
619.228.5886
robert.uhl@westwicke.com
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