APC-400
(tempol) capsule

Adamis has a worldwide license to use Tempol for the treatment of respiratory diseases including asthma, respiratory syncytial virus, influenza and COVID-19.

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Potential Indication: Respiratory Disease (COVID-19, influenza, RSV)

Acute respiratory diseases represent a global health crisis; common symptoms include fever, cough, sore throat, sneezing, runny nose and fatigue; severe cases can progress to pneumonia, acute respiratory distress syndrome (ARDS), acute cardiac injury and eventually death. Adamis conducted a Phase 2/3 clinical trial examining the effects of Tempol in high risk subjects with early COVID-19 infection  (Study Site). The trial did not achieve its primary endpoint, as measured by comparing the rate of sustained clinical resolution of symptoms of COVID-19 at day 14 of Tempol versus placebo. The independent Data Safety Monitoring Board (DSMB) recommended that the study be halted early due to lack of efficacy. The DSMB did note that no safety concerns were identified. The Company has halted the trial and is now analyzing data to determine if Tempol can be utilized in other COVID-19 patient populations or broader respiratory indications. 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.”
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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.

POTENTIAL INDICATION1 PHASE 1 PHASE 2 PHASE 3 NDA APPROVED
APC-400 (tempol) Oral Capsule/Tablet Respiratory Disease / Anti Inflammatory
1 Phase 2/3 clinical trial in high risk subjects with early COVID-19 infection did not achieve its primary endpoint

Published Scientific Articles

Areas of Focus: Allergy, Respiratory and Opioid overdose

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