SAN DIEGO, Feb. 22, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) ("Company") announced today that the U.S. Food and Drug Administration (“FDA”) has completed the safety review of the Company’s Investigational New Drug (“IND”) application and has concluded that Adamis may proceed with the proposed clinical investigation of Tempol for the treatment of COVID-19. The clearance to proceed follows the submission of an IND application to FDA and a Pre-IND meeting.
The goal of the study titled, “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 and the rate of hospitalization for patients taking Tempol versus placebo early in COVID-19 infection. More details of the protocol can be found here or by searching Clinicaltrials.gov.
“As the principal investigator of this study, I am excited to initiate this clinical trial to evaluate the role of Tempol to prevent serious complications and hospitalization in COVID-19 patients. We are in need of additional therapeutic options for COVID-19, and this novel antioxidant approach deserves a thorough investigation,” noted Shyam Kottilil, MBBS, PhD, Professor of Medicine and Director of the Division of Clinical Care and Research at the Institute of Human Virology at the University of Maryland School of Medicine.
Tempol has demonstrated both potent anti-inflammatory, anticoagulant, and antioxidant activity. Both inflammatory cytokines and reactive oxygen species (ROS) from cells of the immune system called macrophages and neutrophils damage the lung in Acute Respiratory Distress Syndrome (ARDS). In animal models, Tempol has been shown to decrease proinflammatory cytokines (cytokine storm), and through its potent antioxidant activity has been shown to decrease the harmful effects of ROS. In addition, Tempol has been shown to decrease platelet aggregation, a problem observed in many COVID-19 patients.
Recently, in collaboration with investigators at the Human Immune Monitoring Center at Stanford University, preliminary data from a study to investigate the effects of Tempol on immune cells from COVID-19 patients showed that Tempol decreased cytokine production in stimulated COVID-19 positive human cells. Numerous published articles describing animal models of ARDS show Tempol caused a decrease in lung inflammation and preserved lung pathology associated with acute and chronic lung injury.
Tempol has also been shown to have an impact on gene expression. Examples include:
(1) Glutathione s-transferase, regulators of oxidative stress - Tempol has been shown to significantly increase the enzyme gene expression, thereby protecting cells against the onslaught of oxidative stress from numerous sources;
(2) ADIPOQ gene, an inflammation regulatory gene - Tempol has been shown to significantly increase expression of ADIPQ, thereby regulating the expression of pro-inflammatory cytokines such as TNF∝ and IL-6; and
(3) HIF-1∝ and HIF-2∝, hypoxia inducible factors - Tempol has been shown to decrease the genes (HIF1∝ and HIF-2∝) associated with hypoxia. Hypoxia is a key indicator often associated with severe disease and poor outcome. Controlling hypoxia and the cytokine store can be considered essential to the successful treatment of COVID-19.
Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals commented: “With new mutations of COVID-19 continuing to occur, there is a distinct possibility that the current vaccines will be less effective. This also holds true for the current antibody products. As the virus continues to mutate, it is likely that this will have a negative impact on viral neutralization. This highlights how critically important it is to develop new therapeutic products. The consequences of cytokine storm caused by COVID-19 remain a major burden on our healthcare system, with few treatment options available. We are hopeful that this study will demonstrate the important role of Tempol in treating and preventing hospitalization and the severe after effects of COVID-19. If this trial is successful, we would likely petition the FDA to consider Emergency Use Authorization for Tempol as a therapeutic treatment for COVID-19”.
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., 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.
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; the timing of commencement of enrollment of patients, conduct or completion of any studies or trials relating to Tempol including the trial discussed in this press release; the results of any studies or trials that the company may conduct relating to Tempol; the impact of Tempol on gene expression; the company’s ability to commercialize the product candidates described in this press release, itself or through commercialization partners; the effectiveness of current or future COVID-19 vaccine products against new mutations of COVID-19; 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 timing of commencement of patient enrollment for trials or studies relating to Tempol, or regarding the timing of the conduct and completion of such clinical trials; that the Tempol trial discussed in this press release will be successful; that future trials or studies regarding Tempol will produce results regarding the impact of Tempol of gene expression or other results that are consistent with the results in previous studies or trials; that Tempol will be found to be safe and effective in the treatment of COVID-19 or any other indication; that we will apply for or that the FDA will grant any emergency use authorization for Tempol for Tempol as a therapeutic treatment for COVID-19; or regarding the effectiveness of current or future COVID-19 vaccine products against new mutations of COVID-19. 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, 2019 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.
Senior Director, Investor Relations
& Corporate Communications
Adamis Pharmaceuticals Corporation