- Adamis Pharmaceuticals Corporation ADMP announced the results from the third planned interim analysis of the Phase 2/3 clinical trial of Tempol in high-risk subjects with early COVID-19 infection.
- The trial 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.
- Last year, the company started dosing in the Phase 2/3 trial for Tempol, which was designed to enroll 248 patients.
- 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.
- Based on the recommendation from the DSMB, the company has halted the trial. It will now evaluate the unblinded data from the trial to determine the next developmental steps for Tempol.
- National Institutes of Health (NIH) identified Tempol as a potentially potent antiviral for COVID-19. According to a study conducted by NIH researchers, Tempol could limit the infection by impairing the activity of a viral enzyme.
- Price Action: ADMP shares are down 45.20% at $0.20 on the last check Wednesday.
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