Adamis Pharmaceuticals Provides Enrollment Update of Subjects in Phase 2/3 Study of Tempol for the Treatment of COVID-19
SAN DIEGO, Feb. 07, 2022 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals (Nasdaq: ADMP) today announced the enrollment and dosing of more than 100 subjects in the Company’s ongoing Phase 2/3 study of Tempol for the treatment of COVID-19. The Data Safety Monitoring Board (DSMB) will now examine clinical and safety data from the first 50 subjects as part of the first interim analysis.
COVID-19 is a complex disease that manifests in multiple phases including, among others, viral replication and hyperinflammation. Preclinical studies of Tempol have shown it to have antiviral, anti-inflammatory, and antioxidant activity. The Company believes this unique mechanism of action, combined with the benign safety profile shown in preclinical and ongoing clinical studies, could provide physicians with a tool to intervene to slow or stop progression of COVID-19 at multiple phases of the disease. If proven, this could provide Tempol with a significant advantage over the two oral antiviral drugs that the FDA has recently granted Emergency Use Authorization (one having a mutagenesis issue and the other having been shown to have drug-drug interaction problems).
Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis, commented, “We are pleased with the rapid speed at which the trial is currently enrolling. The DSMB will now have the task of evaluating the preliminary data. If deemed acceptable, without safety or clinical issues, the trial will continue. The trial is designed to enroll a total of 248 patients. We have also recently applied for FAST Track designation, which, if granted, will allow for the rapid regulatory filing for this trial, if successful. Enrollment in this trial has recently dramatically increased and will likely continue to do so as patients with COVID-19 have limited treatment options, especially with Omicron and future variants arising. We believe that Tempol would fulfill a significant unmet medical need because of its antiviral and anti-inflammatory mechanisms of action. We intend to provide an update on the DSMB review of the interim analysis as the data is verified and statistical programs are validated. We estimate the meeting will convene in March.”
Recently, researchers from the National Institutes of Health (NIH) highlighted Tempol as a potential home antiviral treatment for COVID-19 (https://covid19.nih.gov/news-and-stories/tempol-potential-home-treatment-covid-19).
The Company also recently announced (https://ir.adamispharmaceuticals.com/news-releases/news-release-details/adamis-pharmaceuticals-announces-publication-human-immune) 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 COVID-19 infection.
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 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 Fast Track Designation
Fast Track is a process designed to facilitate the development, and expedite the review, of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions, and the request can be initiated by the drug company at any time during the development process. FDA will review the request and decide based on whether the drug fills an unmet medical need in a serious condition. Once a drug receives Fast Track designation, early and frequent communication between the FDA and the drug company is encouraged throughout the entire drug development and review process.
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 Company’s beliefs concerning the outcome of its Fast Track application to the FDA relating to Tempol; 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 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 are no assurances concerning the amount of time that the DSMB will take to conduct or complete the interim analysis 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 are no assurances that the Company will continue enrollment in the trial following receipt of the analysis of the DSMB. There are no assurances that the FDA will grant Fast Track designation for the Company’s Tempol product candidate. 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 related 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