NIH Discontinues COVID-19 Phase 3 Trial Assessing SAB Biotherapeutics' SAB-185

SAB Biotherapeutics Inc SABS said that due to low hospitalization and death rates in the trial, the National Institutes of Health's (NIH) ACTIV-2 Program is discontinuing enrollment in its Phase 3 COVID-19 trial.
SAB-185 was being assessed as part of Phase 3 ACTIV-2 master protocol evaluating treatments for COVID-19 in patients with mild-moderate infections at higher risk for progression to hospitalization.
Reductions in hospitalization and death rates were included as primary endpoints of the Phase 3 trial.
Related: On Positive Virology Data, SAB Biotherapeutics' COVID-19 Drug To Move To Phase 3 In NIH ACTIV-2 Trial.
The sponsors concluded that the potential efficacy of SAB 185 would not be possible to demonstrate statistically significant clinical efficacy with the existing study design.
SAB Biotherapeutics also announced the publication of nonclinical data from a study highlighting that SAB-185 effectively neutralizes multiple SARS-CoV-2 strains and is superior to convalescent plasma in neutralizing COVID variants.
SAB-185 is a fully human, specifically targeted, broadly neutralizing polyclonal antibody candidate.
Price Action: SABS shares closed 7.46% lower at $4.59 on Tuesday.