Activities Proceeding for Phase 2/3 Trial Examining the Effects of Tempol for the Treatment of COVID-19
SAN DIEGO, June 11, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced that clinical trial start-up activities are underway for examining the effects of Tempol, which is the Company’s experimental drug, in the treatment of COVID-19. Adamis is carrying out these activities with a large clinical research organization (CRO).
Commenced activities include site identification and initiation, data base production, vendor management, and the establishment of an independent data safety monitoring board of infectious disease experts, who will review the safety and efficacy of the trial. Clinical trial drug product and placebo have also been obtained.
The goal of the trial — entitled “A Phase 2/3, Adaptive, Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of Tempol (MBM-02) on Preventing COVID-19 Related Hospitalization in Subjects with COVID-19 Infection” – is to examine the safety and activity of Tempol in COVID-19 patients early in the infection. In addition to safety, the study will examine markers of inflammation, symptoms, and the rate of hospitalization for patients taking Tempol versus placebo. Additional information about the trial can be found on www.clinicaltrials.gov using the identifier NCT04729595.
The clinical trial start-up activities follow recently published work by the National Institutes of Health (NIH), which has identified Tempol as a potentially potent antiviral for COVID-19. As previously reported, in a study of cell cultures conducted by NIH researchers, Tempol demonstrated an ability to limit SARS-CoV-2 infection by impairing the activity of a viral enzyme known as RNA replicase. Tempol produced a 5 log decrease in virus levels in cells infected with SARS-CoV-2. Notably, as a single agent, Tempol performed better in inhibiting RNA replicase than Remdesivir®, which has been approved on an emergency use basis for the treatment of COVID-19. Tempol also synergized with Remdesivir®.
Dr. Dennis Carlo, Chief Executive Officer of Adamis, commented on the start-up activities of the clinical trial: “We believe that additional treatment modalities are sorely-needed for COVID-19 due to the surge of virus variants. Because of Tempol’s mechanism of action, it may inhibit viral replication of all current and future variants of the virus. The results of the NIH studies further support the importance of our clinical trial. The addition of a well-respected data safety monitoring board to the well-designed trial should further increase the likelihood of meaningful clinical data. We look forward to carrying out this trial and helping produce another potential breakthrough treatment for COVID-19.”
Adamis has a worldwide license to use Tempol for the treatment of respiratory diseases including asthma, respiratory syncytial virus, influenza and COVID-19.
For additional information on Tempol and its potential use as a treatment for COVID-19, see the presentation by Dr. Ronald Moss, Chief Medical Officer of Adamis, to the European Society of Medicine “Novel effects of Tempol for the treatment of COVID19” (https://www.youtube.com/watch?v=F1Pd4qG-MbY).
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. Adamis’ naloxone injection product candidate, ZIMHI, for the treatment of opioid overdose is currently under FDA review. Adamis is developing additional products, including treatments for acute respiratory diseases, such as COVID-19, influenza, asthma, and COPD. The company’s subsidiary, US Compounding Inc. (USC), compounds sterile prescription drugs, and certain nonsterile drugs for human and veterinary use by hospitals, clinics, surgery centers, and vet clinics throughout most of the United States. For additional information about Adamis Pharmaceuticals, please visit www.adamispharmaceuticals.com.
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: the Company’s beliefs concerning the safety and effectiveness of Tempol or the Company’s other product candidates; the timing of funding for, or commencement or completion of, any studies or trials relating to Tempol; the results of any studies or trials that the Company may conduct 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 protection afforded by patents and patent applications that it owns or has licensed, and its ability to enforce its patents and other intellectual property rights against third parties; and other statements concerning our 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 outcome of trials or studies relating to, Tempol; the timing or outcome of any such studies or trials; 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 USC recently 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, as well as the related 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.
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