Benzinga | Jun 7, 2021 07:32AM EDT

Adamis Highlights National Institute of Health Study Identifying Tempol as a Potential Antiviral Drug for COVID-19

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.