Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today provided an update on 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. The next Data Safety Monitoring Board (DSMB) meeting to review interim data results has been scheduled for late September. 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.
The DSMB is comprised of infectious disease experts who independently review the unblinded trial data and make recommendations. The Company will not have access to unblinded trial data until the trial has concluded. 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. If the DSMB recommendations indicate that the analysis of the clinical and safety data from the trial demonstrates significant efficacy, Adamis would submit a clinical study report to the FDA and request a meeting to discuss the findings and next steps for continued clinical development. If positive trends are observed in favor of the Tempol treatment group, the DSMB may recommend continuing the study along with the enrollment of additional subjects. If no efficacy is demonstrated, then the Company would likely stop the trial.
“We are committed to continue advancing Tempol for the treatment of COVID-19, especially with the recent increase of cases due to new variants,” said David J. Marguglio, President and Chief Executive Officer of Adamis Pharmaceuticals. “With more than 200 patients enrolled, we believe this next DSMB data review could provide important additional insights into the safety and treatment effects of Tempol, as well as the future clinical path for Tempol.”
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