Benzinga | Jun 11, 2021 07:32AM EDT

Adamis Pharma Offers Update On Clinical Trial Start-Up Progress For Tempol In Treatment Of COVID-19

Activities Proceeding for Phase 2/3 Trial Examining the Effects of Tempol for the Treatment of COVID-19

SAN DIEGO, June 11, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced that clinical trial start-up activities are underway for examining the effects of Tempol, which is the Company's experimental drug, in the treatment of COVID-19. Adamis is carrying out these activities with a large clinical research organization (CRO).

Commenced activities include site identification and initiation, data base production, vendor management, and the establishment of an independent data safety monitoring board of infectious disease experts, who will review the safety and efficacy of the trial. Clinical trial drug product and placebo have also been obtained.

The goal of the trial -- entitled "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 examine the safety and activity of Tempol in COVID-19 patients early in the infection. In addition to safety, the study will examine markers of inflammation, symptoms, and the rate of hospitalization for patients taking Tempol versus placebo. Additional information about the trial can be found on www.clinicaltrials.gov using the identifier NCT04729595.

The clinical trial start-up activities follow recently published work by the National Institutes of Health (NIH), which has identified Tempol as a potentially potent antiviral for COVID-19. As previously reported, in a study of cell cultures conducted by NIH researchers, Tempol demonstrated an ability to limit SARS-CoV-2 infection by impairing the activity of a viral enzyme known as RNA replicase. Tempol produced a 5 log decrease in virus levels in cells infected with SARS-CoV-2. Notably, as a single agent, Tempol performed better in inhibiting RNA replicase than Remdesivir(r), which has been approved on an emergency use basis for the treatment of COVID-19. Tempol also synergized with Remdesivir(r).

Dr. Dennis Carlo, Chief Executive Officer of Adamis, commented on the start-up activities of the clinical trial: "We believe that additional treatment modalities are sorely-needed for COVID-19 due to the surge of virus variants. Because of Tempol's mechanism of action, it may inhibit viral replication of all current and future variants of the virus. The results of the NIH studies further support the importance of our clinical trial. The addition of a well-respected data safety monitoring board to the well-designed trial should further increase the likelihood of meaningful clinical data. We look forward to carrying out this trial and helping produce another potential breakthrough treatment for COVID-19."

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

For additional information on Tempol and its potential use as a treatment for COVID-19, see the presentation by Dr. Ronald Moss, Chief Medical Officer of Adamis, to the European Society of Medicine "Novel effects of Tempol for the treatment of COVID19" ( https://www.youtube.com/watch?v=F1Pd4qG-MbY).