Adamis Pharmaceuticals ADMP announced that it has achieved the initial planned enrollment goal in the ongoing U.S. Phase 2/3 clinical trial of Tempol as a treatment for COVID-19.

The Phase 2/3 study evaluating the effects of Tempol (MBM-02) in patients infected with COVID-19, designed to enroll approximately 248 high-risk subjects with early COVID-19 infection between the ages of 18 and over.

The Data Safety Monitoring Board (DSMB) previously met to assess clinical and safety data from the interim analyzes in March and June 2022, and both times recommended that the study continue without modification

At the September meeting, the DSMB plans to assess the primary efficacy endpoint, sustained resolution of COVID-19 symptoms, as well as safety in individuals at high risk of disease progression for about 190 subjects.

Ron Moss, MD, Chief Medical Officer, said, “We are very pleased to have reached this important trial milestone and look forward to the next DSMB meeting later this month. This interim meeting is important because it will mark the first time the DSMB will evaluate statistical measures of effectiveness for Tempol. If interim data or final clinical data show positive results, we will submit a clinical study report to the FDA and request a meeting to discuss the results and the possibility of emergency use authorization. The Agency has approved two antivirals under EUA for outpatients with COVID-19. Whatever form COVID-19 takes in the future, we believe there will always be a medical need and a significant market for effective new therapies.

The Data Safety Monitoring Board (DSMB) is made up of infectious disease experts who independently review data from unblinded trials and make recommendations.

Price Action: Adamis shares are trading around 1% higher at $0.36 on Monday during the after-hours session.