Adamis Pharmaceuticals ADMP announced that it has reached the initial planned enrollment target in the ongoing U.S. Phase 2/3 clinical trial investigating Tempol as a treatment for COVID-19.
The Phase 2/3 Study evaluating the effects of Tempol (MBM-02) in patients with COVID-19 infection, designed to enroll approximately 248 high risk subjects with early COVID-19 infection age 18 years of age and older.
The Data Safety Monitoring Board (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
In 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.
Ron Moss, M.D., Chief Medical Officer, stated, "We are very pleased to reach this trial milestone and eagerly await the next DSMB meeting later this month. This interim meeting is significant as it will mark the first time the DSMB evaluates statistical measures of efficacy for Tempol. If either the interim data or the final clinical data shows positive results, we would submit a clinical study report to the FDA and request a meeting to discuss the findings and the potential for Emergency Use Authorization. The Agency has approved two oral antivirals under EUA for outpatients with COVID-19. Regardless of what form COVID-19 takes going forward, we believe there will always be a medical need and large market for new effective therapeutics."
The Data Safety Monitoring Board (DSMB) is comprised of infectious disease experts who independently review the unblinded trial data and make recommendations.
Price Action : Adamis shares are trading around 1percent higher at $0.36 on Monday during after-hours session.
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