Adamis Pharmaceuticals Corporation announced on March 15 that its Tempol antioxidant product decreased COVID-related lung inflammation in hamsters during studies conducted at Galveston National Laboratory (GNL). GNL, located on the campus of the University of Texas Medical Branch (UTMB) at Galveston, is part of the National Institute of Allergy and Infectious Diseases Biodefense Laboratory Newtork.
In the study, hamsters challenged with the virus that causes COVID-19 (SARS-CoV-2) had less inflammation in the lungs when treated with Tempol compared with controls. These are 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.
“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,” said 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.
These results are also consistent with the results that Adamis 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.
“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,” said Dr. Ronald Moss, Chief Medical Officer of Adamis,