Adamis Pharmaceuticals (ADMP) Cleared to Proceed with Human Studies of Tempol for the Treatment of COVID-19

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”.

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