Adamis Pharmaceutics Corporation announced t that the third planned interim analysis of the Phase 2/3 clinical trial examining the effects of Tempol in high risk subjects with early COVID-19 infection did not achieve its primary endpoint, as measured by comparing the rate of sustained clinical resolution of symptoms of COVID-19 at day 14 of Tempol versus placebo. The independent Data Safety Monitoring Board (DSMB) recommended that the study be halted early due to lack of efficacy. The DSMB did note that no safety concerns were identified in the subjects that received Tempol.

Based on the recommendation from the DSMB, the Company has halted the trial and will now evaluate the unblinded data from the trial to determine the next developmental steps for Tempol. This trial did not meet its primary endpoint, but are exploring the possibility that vaccinations and the less virulent variants (Omicron) during the trial period may have obscured an effect of Tempol. This speculation is based on the lower-than-expected observed hospitalization rate in this trial (less than 1%) compared to other COVID-19 treatment trials.