Adamis Pharmaceuticals Corporation announced that the Company's ongoing U.S. Phase 2/3 clinical trial to evaluate the safety and efficacy of Tempol as a treatment for COVID-19 has reached the initial planned enrollment of 248 subjects. The Data Safety Monitoring Board (DSMB) is comprised of infectious disease experts who independently review the unblinded trial data and make recommendations. The DSMB previously met to evaluate the clinical and safety data from interim analyses in March and June 2022, and both times recommended that the study continue without modification.

At the September meeting, the DSMB plans to evaluate the primary efficacy endpoint, the sustained resolution of COVID-19 symptoms, as well as safety in individuals who are at high risk for disease progression for approximately 190 subjects. If analysis of the interim clinical data showed significant efficacy, the DSMB may recommend stopping the trial because it has already demonstrated statistical significance. If the interim data indicated no efficacy on the primary endpoint, the DSMB would likely recommend stopping the trial for futility.

Under that outcome, the Company would begin analyzing the then unblinded data to determine if there were efficacy on the secondary endpoints. If positive efficacy trends are observed on the primary endpoint in favor of Tempol, but statistical significance is not reached, the DSMB may recommend continuing the trial and enrolling additional patients to further power the study.