Ad-hoc DSMB meeting evaluates interim clinical and safety data and clears Phase 2/3 study to continue
SAN DIEGO, Feb. 28, 2022 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) today announced that due to the acceleration of patient enrollment in the double-blind placebo controlled Phase 2/3 trial for Tempol for the treatment of COVID-19, an ad-hoc meeting of the Data Safety Monitoring Board (DSMB) was held 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 analysis of the data, the DSMB determined that the study can continue, as there were no safety or clinical concerns identified. The data from the first 50 subjects will be reviewed again in March when the DSMB will examine additional clinical and safety data as part of the first planned interim analysis.
“We are pleased with the progress of the trial, which has already exceeded the required number of subjects (124) for the second planned interim DSMB analysis,” said Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals. “We appreciate the feedback from the DSMB. Following the first planned interim analysis, if the DSMB advises for the study to continue, we will also report on the second planned DSMB review following its completion, which may provide additional insight into the safety and clinical results at that time.”
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. Additionally, independent researchers from the National Institutes of Health (NIH) recently highlighted Tempol as a potential home antiviral treatment for COVID-19 (https://covid19.nih.gov/news-and-stories/tempol-potential-home-treatment-covid-19).
In contrast to two recently Emergency Use Authorization (EUA) approved oral antivirals for the treatment of COVID-19, Adamis Pharmaceuticals believes that Tempol addresses an unmet medical need because of its unique multiple mechanisms of action and well tolerated safety profile shown in previous preclinical studies.
About the Phase 2/3 Clinical 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 (https://www.zimhi.com/). 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 www.adamispharmaceuticals.com 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 enrollment of patients in 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 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; the opinions and beliefs of third parties identified 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 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, including those relating to Tempol; 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 the interim analyses and reviews described in this press release, concerning the results or outcome of that analysis, or concerning what decisions the Company will make after receiving information concerning 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, 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 other governmental investigations or proceedings. 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.
Adamis Investor Relations
Source: Adamis Pharmaceuticals Corporation