Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) dropped 1.96% after the company announced that start-up activities for the clinical trial of its experimental COVID-19 treatment, Tempol, are underway. The company is conducting the activities in collaboration with an extensive clinical research organization.
Adamis commence activities on a COVID-19 treatment study
Already, site selection and initiation, vendor management, database generation, and forming an independent data safety monitoring board of infectious disease experts, who will examine the trial’s safety and efficacy, have all begun. A placebo and a clinical trial medication product were also obtained.
The purpose of the study, dubbed “A Phase 2/3, Adaptive, Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of Tempol (MBM-02) on Preventing COVID-19 Related Hospitalization in Subjects with COVID-19 Infection,” is to establish how safe and effective Tempol is in COVID-19 patients early in the infection. The trial will look at signs of inflammation, symptoms, and hospitalization rate for people taking Tempol vs. those on placebo.
The clinical trial preparations come after the National Institutes of Health (NIH) recently published research identifying Tempol as a possible COVID-19 antiviral. Tempol showed SARS-CoV-2 infection inhibition ability by reducing the functioning of a viral enzyme called RNA replicase in a cell culture study conducted by NIH researchers. In cells infected with SARS-CoV-2, Tempol reduced viral levels by 5 logs. Tempol performed better as a single drug in suppressing RNA replicase, unlike Remdesivir®, currently approved for COVID-19 treatment.
Tempol possible COVID-19 treatment
Commenting in the clinical trial start-up activities, Adamis’ CEO Dennis Carlo stated that due to the increasing number of viral variations, there is need for further treatment options for COVID-19. He said that Tempol’s mechanism of action could prevent all existing and future virus strains from replicating. The NIH investigation findings add to the significance of Adamis’ clinical investigation.