NIH Researchers Contend “Tempol may be a Promising Oral Antiviral Treatment for COVID-19”
Research Team Intends to Conduct Additional Studies, Including a Prospective Clinical Study for Tempol in the Treatment of COVID-19
SAN DIEGO, June 07, 2021 — Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) today highlighted that the National Institutes of Health (NIH) has identified its experimental drug, Tempol, as a potentially potent antiviral for COVID-19. According to 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. The NIH researchers also found that Tempol “doses used in their antiviral studies could be likely achieved in tissues that are the primary targets for the virus.”1
The June 3rd announcement issued by the NIH noted that the study team was led by researchers from the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The team also included researchers from the National Cancer Institute, the National Institute of Allergy and Infectious Diseases and the National Institute of Neurological Disorders and Stroke.
Additional study details disclosed include:
- Researchers discovered Tempol’s effectiveness by assessing a basic question of how the virus utilizes its RNA replicase, which is an enzyme that enables SARS-CoV-2 to replicate its genome and make copies of itself when inside a cell.
- Researchers tested if RNA replicase and the enzyme’s nsp12 sub-unit require iron-sulfur clusters for structural support.
- Findings indicate that the SARS-CoV-2 RNA replicase requires two iron-sulfur clusters to function optimally.
- Earlier studies mistakenly identified these iron-sulfur cluster binding sites as zinc-binding sites.
- Researchers found that Tempol can degrade iron-sulfur clusters.
- Researchers intend to conduct additional studies and will evaluate Tempol in a clinical study for COVID-19.
Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis, commented: “We are very pleased the NIH study has demonstrated that Tempol – which has previously shown both anti-inflammatory and anti-oxidant capability – is also a promising potential antiviral treatment for COVID-19. The NIH results, along with other data, suggest Tempol is well-suited for further study for use in the early treatment of COVID-19.”
The NIH study follows studies conducted in collaboration with Galveston National Laboratory and the University of Texas Medical Branch at Galveston. These studies entailed hamsters being challenged with SARS-CoV-2 receiving TEMPOL as a treatment. The TEMPOL-treated animals showed decreased lung inflammation compared to controls.
Earlier this year, Adamis announced that in-vitro inflammatory cytokine data from a study done in collaboration with Stanford University showed that TEMPOL significantly inhibited the release of multiple inflammatory cytokines from activated immune cells of COVID-19 patients. The Stanford study suggested Tempol may prevent the cytokine storm observed in COVID-19 patents.
The Company believes that the results from the NIH study also support the design and implementation of the protocol in Adamis’ Investigational New Drug Application to study Tempol in early COVID-19 infection. The goal of this 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, COVID-19 symptoms, 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 www.clinicaltrials.gov and using the identifier NCT04729595.
Adamis has previously licensed exclusive worldwide rights under patents, patent applications and related know-how to use Tempol for the treatment of respiratory diseases including asthma, respiratory syncytial virus, influenza and COVID-19, as well as the use of Tempol as a therapeutic for reducing 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. 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.
Adamis Investor Relations
1 National Institutes of Health, “NIH researchers identify potential new antiviral drug for COVID-19,” June 3, 2021.