Adamis tanks as Phase II/III Tempol trial in COVID-19 fails

USA-based Adamis Pharmaceuticals (Nasdaq: ADMP) saw its shares plunge as much as 42% yesterday, after releasing disappoint trial results of its COVID-19 treatment candidate.

The specialty pharma firm said that the third planned interim analysis of the Phase II/III clinical trial examining the effects of Tempol, a novel antioxidant, 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 study to determine the next developmental steps for Tempol.