Benzinga | Jan 24, 2022 09:26AM EST

On Positive Virology Data, SAB Biotherapeutics' COVID-19 Drug To Move To Phase 3 In NIH ACTIV-2 Trial

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.