Adamis Pharmaceuticals Announces Tempol Reduces Lung Inflammation in the COVID-19 Challenged Hamster Model

Rhea-AI Summary

Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) announced significant findings from studies at the University of Texas Medical Branch, revealing that Tempol, a novel antioxidant, effectively reduces lung inflammation in COVID-19 challenged hamsters. This marks the first data confirming Tempol's anti-inflammatory properties in this context. The company plans to submit findings for peer review and is preparing for a Phase 2/3 clinical trial to evaluate Tempol's safety and efficacy in early COVID-19 patients. The trial aims to assess how Tempol affects inflammation markers and hospitalization rates.

Positive

• Demonstrated Tempol's efficacy in reducing pulmonary inflammation in COVID-19 challenged hamsters.
• Upcoming Phase 2/3 trial aims to assess Tempol's safety and activity in early COVID-19 infection.

Negative

• None.

SAN DIEGO, March 15, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) ("Company") announced today that in studies conducted at Galveston National Laboratory (GNL), University of Texas Medical Branch (UTMB) at Galveston, hamsters challenged with the virus that causes COVID-19 (SARS-CoV-2), resulted in decreased inflammation in the lungs of animals treated with Tempol compared to controls. This is the first data demonstrating that Tempol, a novel antioxidant, can reduce inflammation in animals given the virus (SARS-CoV-2) that causes COVID-19. The group plans on submitting the publication to a peer review journal.

Dr. Chien-Te Kent Tseng, Professor of 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 COVID-19 model, pulmonary inflammation with cellular infiltrates and hemorrhage (mild-to-moderate) is triggered by SARS-CoV-2 infection. Treatment with Tempol reduces the overall inflammatory responses and appears to start repairing damaged lungs.”

These results are also consistent with the results that the Company announced regarding in-vitro cytokine data from Stanford University. The results demonstrated that incubation of Tempol significantly suppresses multiple inflammatory cytokines from cells taken from COVID-19 patients.

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). Tempol has now been shown to: (1) Decrease the proinflammatory cytokines (cytokine storm) in animal models (lipopolysaccharide induced), (2) Suppress cytokines in stimulated COVID-19 positive human cells, and (3) Reduce inflammation in hamsters challenged with COVID-19. In addition, Tempol has been shown to decrease platelet aggregation, a problem observed in many COVID-19 patients.

The new results demonstrating decreased lung inflammation in hamsters challenged and treated with Tempol are consistent with the design of the recent FDA allowed IND and protocol to study Tempol in early COVID-19 infection. 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. Dr. Ronald Moss, Chief Medical Officer of Adamis, commented: “These results from a validated animal model for COVID-19 provide further support on implementing our well-designed clinical trial in order to obtain activity and safety information on the use of Tempol in early COVID-19 infection in humans.”

Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, commented: “The results to date support the design of our clinical study in that we are targeting early infection with the objective of reducing lung inflammation and eventual hospitalization. We are hopeful that the clinical study will replicate the results obtained to date, i.e., preventing or ameliorating some of the most severe symptoms of COVID-19 caused by dysfunctional inflammation.”

In addition to Dr. Tseng, the UTMB team includes Drs. Aleksandra K. Drelich, Kempaiah Rayavara Kempaiah, and Bi-Hung Peng (Pathologist).

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 or the company’s other product candidates; the timing of commencement or completion of 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; 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 trials relating to Tempol, the timing of completion of such trials or the outcome of such trials, that the company’s planned Phase 2/3 study will produce results that are consistent with earlier preclinical or clinical studies or trials 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 most recent annual report on Form 10-K 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

Mark Flather
Senior Director, Investor Relations
& Corporate Communications
Adamis Pharmaceuticals Corporation
(858) 412-7951
mflather@adamispharma.com

FAQ

What did Adamis Pharmaceuticals announce on March 15, 2021 regarding Tempol?

On March 15, 2021, Adamis Pharmaceuticals announced that Tempol reduced lung inflammation in hamsters infected with the virus causing COVID-19, indicating its potential use in treating the disease.

What is the goal of Adamis' upcoming clinical trial for Tempol?

The goal of the upcoming Phase 2/3 clinical trial for Tempol is to evaluate its safety and effectiveness in reducing hospitalization rates and inflammation in patients with early COVID-19 infection.

How does Tempol work according to Adamis' studies?

Tempol has shown anti-inflammatory, anticoagulant, and antioxidant activity, reducing proinflammatory cytokines and inflammation caused by COVID-19 and ARDS.

What previous results support the effectiveness of Tempol?

Previous studies by Stanford University indicated that Tempol significantly suppresses inflammatory cytokines from COVID-19 patients' cells, supporting its proposed use in clinical settings.

Which laboratory conducted the studies on Tempol?

The studies on Tempol were conducted at the Galveston National Laboratory, University of Texas Medical Branch, in Galveston.