Adamis Pharmaceuticals Announces Results of Tempol in Omicron Virus Challenge in Hamster Model

Rhea-AI Summary

Adamis Pharmaceuticals Corporation (ADMP) has announced findings from studies at Galveston National Laboratory showing that Tempol significantly reduces lung inflammation in hamsters challenged with the Omicron variant of SARS-CoV-2.

Dr. Tseng from UTMB noted the potential of Tempol as a treatment, especially as the Omicron BA.2 variant rises in prevalence in the US. The results support ongoing clinical studies aimed at mitigating symptoms related to COVID-19.

Positive

• Significant reduction of lung inflammation in hamsters treated with Tempol after high-dose Omicron exposure.
• Supports ongoing clinical study aiming to reduce COVID-19 symptoms.

Negative

• None.

Tempol Reduced Lung Inflammation After High Dose Challenge

SAN DIEGO, March 22, 2022 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) today announced that in studies conducted at Galveston National Laboratory (GNL), University of Texas Medical Branch (UTMB) at Galveston, hamsters challenged with high levels of the Omicron variant of the SARS-CoV-2 virus, resulted in significant decrease of inflammation in the lungs of animals treated with Tempol compared to controls. The Company previously reported data demonstrating that Tempol, a novel antioxidant, can reduce inflammation in hamsters given the original non-variant wild-type virus (SARS-CoV-2) strain that causes COVID-19.

Dr. Chien-Te Kent Tseng, Professor in the Department of Microbiology and Immunology and Director of GNL’s SARS/MERS/COVID-19 Laboratory at UTMB, commented on these results: “In our hamster model using high doses of omicron virus, we observe significant pulmonary inflammation. In contrast, animals given Tempol show a significant reduction of inflammation. Tempol acts as a potent anti-inflammatory in the hamster challenge model, which we believe is an appropriate model for human COVID-19.” In addition to Dr. Tseng, the UTMB team includes Drs. Aleksandra K. Drelich and Bi-Hung Peng (Pathologist).

Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals commented: “The new Omicron variant BA.2 is predicted to increase in the US over the next few weeks. The Centers for Disease Control and Prevention data show BA.2, which is a subvariant of omicron, has been tripling in prevalence every two weeks. The recent Tempol animal study shows significant decrease in lung inflammation in hamsters given high doses of Omicron. It is encouraging since we have seen similar effects in the wild type unmutated virus. The ongoing evolutionary changes of the virus create challenges for vaccines and there are limited safe treatment options against these new variants. These data support the potential for Tempol to play an important role, as a medical countermeasure, to the ongoing evolutionary changes in the virus that causes COVID-19. The animal study results to date also support the design of our ongoing clinical study in humans where we are targeting early infection with the objective of reducing inflammation and a more rapid resolution of symptoms. We are hopeful that the clinical study will replicate the animal study results, i.e., preventing or ameliorating some of the most severe symptoms of COVID-19 caused by dysfunctional inflammation, regardless of the virus variant.”

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. 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 Adamis.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 variants of COVID-19; statements concerning the GNL animal study results using Tempol; the Company’s beliefs concerning the mechanisms of action, safety and effectiveness of Tempol; the timing, progress or results of the Company’s Phase 2/3 clinical trial for Tempol or other studies or trials relating to Tempol as a treatment for COVID-19; the opinions and beliefs of any third parties identified in this press release concerning the potential of Tempol as a treatment for COVID-19 and the results of previous animal 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 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. 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.

Contact:

Adamis Investor Relations
Robert Uhl
Managing Director
ICR Westwicke
619.228.5886
robert.uhl@westwicke.com

FAQ

What did the recent Adamis Pharmaceuticals press release announce regarding Tempol?

Adamis Pharmaceuticals announced that Tempol significantly reduced lung inflammation in hamsters exposed to the Omicron variant of SARS-CoV-2.

How does Tempol work according to Adamis Pharmaceuticals?

Tempol acts as a potent anti-inflammatory, reducing inflammation in lungs after high doses of the Omicron variant.

What is the significance of the study conducted at Galveston National Laboratory?

The study is significant as it shows Tempol's potential effectiveness against COVID-19 variants, particularly as the BA.2 strain spreads in the US.

What are the future plans for Tempol according to Adamis Pharmaceuticals?

Adamis plans to continue clinical trials targeting early COVID-19 infection with the goal of reducing inflammation and symptoms.

What variant of COVID-19 is currently of concern in the Adamis Pharmaceuticals release?

The Omicron BA.2 variant is currently of concern as noted in Adamis Pharmaceuticals' press release.