SAB Biotherapeutics Inc (NASDAQ:SABS) has reported positive Phase 2 safety and efficacy data demonstrating that SAB-185 met the criteria required to move to Phase 3 in the National Institutes of Health (NIH) COVID-19 ACTIV-2 Trial.
- SAB-185 is a fully human, specifically targeted, broadly neutralizing polyclonal antibody candidate for high-risk non-hospitalized patients with mild to moderate COVID-19.
- SAB-185 met the criteria for advancement to Phase 3 with Day 3 viral load data from the pre-specified interim analysis.
- Related: FDA Lab Testing Confirms SAB Biotherapeutics' COVID-19 Antibody Neutralizes Omicron Variant.
- The ongoing Phase 3 ACTIV-2 trial is a non-inferiority randomized, unblinded, active comparator-controlled study assessing the safety and efficacy of SAB-185 compared to an active control monoclonal antibody treatment.
- It is enrolling approximately 600 participants to receive SAB-185 and 600 to receive the active comparator.
- Price Action: SABS shares are up 1.28% at $5.55 during the premarket session on the last check Monday.
