Tempol – Oral Capsule
Potential Indication: Respiratory Disease (COVID-19, influenza, RSV)
Adamis has initiated patient dosing in a Phase 2/3 clinical trial for Tempol (Study Site), its oral antiviral product candidate. The trial is designed to enroll 248 unvaccinated subjects with early COVID-19 infection 18 years of age and older. The primary endpoint is the rate of hospitalization for patients receiving Tempol, versus those receiving placebo. Eligible subjects with positive COVID-19 infection within five days of study entry will be randomized 1:1 to receive either Tempol or placebo. Patients randomized to Tempol (n=124), will receive 800mg daily in two divided doses of 400mg for up to 14 days. Similarly, placebo capsules will be administered twice daily to subjects in the placebo group (n=124) for up to 14 days.
Recent research from the National Institutes of Health (NIH) has identified Tempol as a potentially potent antiviral for COVID-19. According to a study of cell cultures conducted by NIH researchers and published in Science (NIH Article), 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.”
In August 2021, Adamis announced (Stanford Study) the results of a published study in collaboration with Stanford University researchers suggesting that Tempol has strong, broad in-vitro anti-cytokine activity. Suppression of inflammatory cytokines with an antioxidant may be a beneficial treatment strategy in early COVID-19 infection.
Additional published studies, in which animals were infected with betacoronavirus, show that Tempol treatment resulted in increased survival and decreased viral load. Taken together, this scientific data argue for the use of Tempol in preventing and treating the most severe death related lung manifestation of COVID-19. Tempol has already been shown to be well tolerated in human clinical studies to date.