Enrollment update of subjects in phase II/III study of Tempol for the treatment of COVID-19.
Adamis Pharmaceuticals Corporation announced the enrollment and dosing of more than 100 subjects in the Company’s ongoing Phase II/III study of Tempol for the treatment of COVID-19.
The Data Safety Monitoring Board (DSMB) will now examine clinical and safety data from the first 50 subjects as part of the first interim analysis.
COVID-19 is a complex disease that manifests in multiple phases including, among others, viral replication and hyperinflammation. Preclinical studies of Tempol have shown it to have antiviral, anti-inflammatory, and antioxidant activity. The Company believes this unique mechanism of action, combined with the benign safety profile shown in preclinical and ongoing clinical studies, could provide physicians with a tool to intervene to slow or stop progression of COVID-19 at multiple phases of the disease.
If proven, this could provide Tempol with a significant advantage over the two oral antiviral drugs that the FDA has recently granted Emergency Use Authorization (one having a mutagenesis issue and the other having been shown to have drug-drug interaction problems).
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