Shares of Adamis Pharmaceuticals Corporation ( ADMP Quick Quote ADMP - Free Report) surged 77.6% after it submitted an investigational new drug (IND) application to the FDA to begin a clinical study onTempol for thetreatment and prevention ofCOVID-19. The submission of the IND was done after the company had a Pre-IND meeting with the FDA, in which the agency gave specific recommendations on Chemistry, Manufacturing and Controls (CMC) and Clinical aspects to be included in the IND. In the past year, shares of the company have increased 194.8% compared with the industry’s growth of 5%.
The company plans to seek government and/or non-government funding to conduct the study. Tempol has demonstrated a unique antioxidant and anti-inflammatory activity in pre-clinical studies. Tempol specifically targets Acute Respiratory Distress Syndrome (ARDS), which is the major cause of death inCOVID-19 patients. The study data showed that Tempol lowered the harmful effects of reactive oxygen species (ROS). Further, tempol decreased platelet aggregation, a problem that is observed in many COVID-19 patients. Tempol has also been effective in decreasing the genes related to hypoxia. Hypoxia is detrimental with severe disease and a poor outcome. Controlling hypoxia and the cytokine storm can be considered essential to the successful treatment of COVID-19. Per Adamis, tempol could play a vital role not only in the treatment of COVID-19 but actually in preventing hospitalization. Adamis in-licensed tempol from Matrix. The license includes the worldwide use of Tempol for the treatment of all respiratory diseases, including asthma, respiratory syncytial virus, influenza and COVID-19. Several other companies have also come up with treatments for this virus. In November 2020, the FDA granted emergency use authorization to two monoclonal antibody treatments – Eli Lilly’s ( LLY Quick Quote LLY - Free Report) bamlanivimab and a combination of casirivimab and imdevimab, made by Regeneron ( REGN Quick Quote REGN - Free Report) . Both treatments have been approved for non-hospitalized adults and children above the age of 12 with mild to moderate COVID-19 symptoms who are at risk for developing severe COVID-19 or being hospitalized for it. Gilead Sciences’ ( GILD Quick Quote GILD - Free Report) antiviral drug, Veklury (remdesivir), was approved by the FDA in October 2020 to treat COVID-19. The drug may be used to treat adults and children aged 12 years and older and weighing at least 88 pounds, who have been hospitalized for COVID-19.
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