SABS - SAB says NIH discontinuing phase 3 trial of COVID drug SAB-185 as hospitalizations decline

SAB Biotherapeutics (NASDAQ:SABS) said the National Institutes of Health (NIH) is closing enrollment in its ACTIV-2 trial due to low Omicron-related COVID-19 hospitalization and death rates that have made the current study design statistically unworkable. SAB-185 was being evaluated as part of the Phase 3 ACTIV-2 master protocol assessing treatments for COVID-19 in patients with mild-moderate infections at higher risk for progression to hospitalization. The company said reductions in hospitalization and death rates were included as main goals of the study. But since so few of the enrolled patients had an observable study endpoint event such as hospitalization, it would not be possible to show statistically significant clinical efficacy. SAB-185 had previously met the initial pre-specified safety and efficacy criteria to continue to the next phase. SAB noted that it is evaluating future clinical plans for SAB-185 including potential targeted applications such as prophylaxis and treatment in high-risk patient groups.

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SAB says NIH discontinuing phase 3 trial of COVID drug SAB-185 as hospitalizations decline