NIH Discontinues COVID-19 Phase 3 Trial Assessing SAB Biotherapeutics' SAB-185
- SAB Biotherapeutics Inc (NASDAQ: 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.
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