Adamis Pharmaceuticals Corporation announced the submission of a Fast Track Application to the U.S. Food and Drug Administration (FDA) for Tempol for the treatment and prevention of COVID-19. Tempol is currently being studied in a Phase 2/3 clinical trial in adult patients with confirmed COVID-19 infection. Tempol has been shown to have antiviral, anti-inflammatory, and antioxidant activity. Although recent oral antiviral drugs have been approved by the FDA, the Company believes that Tempol would provide an unmet medical need because of its unique mechanism of action and safety profile.
Shyam Kottilil, MBBS, Ph.D., Professor of Medicine at the University of Maryland School of Medicine (UMSOM), Chief of the Division of Clinical Care and Research at UMSOM’s Institute of Human Virology, and Principal Investigator for the ongoing Tempol clinical trial, commented: “We are currently observing extremely high COVID-19 infection rates and we urgently need additional safe and effective oral agents. I am pleased with the conduct of the ongoing clinical trial thus far. If positive effects are observed and result from Tempol’s ongoing clinical trial, I believe that this drug should be expedited through the approval process. Tempol as an oral antiviral and anti-inflammatory agent may be an important countermeasure, if proven safe and effective in this trial.”
Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis, commented, “Our ongoing clinical trial is continuing, as we see a surge in COVID-19 infections in the U.S. and worldwide. Concerns have been expressed about potential safety questions for EUA approved antivirals such as mutagenesis and drug-drug interactions (Molnupiravir: long-term safety questions linger as approvals approach (pharmaceutical-technology.com)) (https://www.fda.gov/media/155050/download). We are thus applying for Fast Track designation to the FDA to expedite the regulatory approval pathway for Tempol. Because Tempol has both anti-inflammatory and antiviral effects, we believe that Tempol fulfills an unmet medical need as an oral agent, focusing on multiple aspects of the pathogenesis of COVID-19 disease.”