SAB Biotherapeutics COVID-19 Candidate to Advance to Phase 3 Trials

SAB Biotherapeutics (SAB) is focused on revolutionizing immunotherapies. They operate as a clinical-stage biopharmaceutical company, utilizing their proprietary immunotherapy platform to produce specifically targeted, high-potency, fully-human polyclonal antibodies. Part of the revolutionary aspect of this technology is that it does not require human donors at all. Recently, SAB received positive news from an independent Data Safety Monitoring Board (DSMB) regarding the safety and efficacy of SAB-185 – their current therapeutic candidate for patients with moderate COVID-19.

SAB-185 has been subjected to a prespecified interim analysis data review, evaluating the safety and efficacy in the Phase 2 portion of the ACTIV-2 trial. The DSMB has given full approval and recommended advancement to Phase 3, a major milestone for their platform.

SAB-185 is a fully-human, specifically-targeted, broadly-neutralizing polyclonal antibody therapeutic candidate for the treatment of non-hospitalized patients with moderate COVID-19. After meeting the predefined graduation criteria, this candidate will move to Phase 3 trials, showing it has true potential to become a valuable therapy. Following Phase 3, if successful, SAB will work on scaling up production to make their therapy as widely available as needed. 

The Phase 3 portion of the ACTIV-2 trial is a randomized, unblinded, active comparator-controlled adaptive platform study that will assess the clinical safety and efficacy of SAB-185 compared to active control monoclonal antibody treatment in people with mild to moderate COVID-19 who are at higher risk for progression to hospitalization, enrolling approximately 600 participants to receive the investigational agent SAB-185 and 600 to receive an active comparator. The primary outcome measures of the Phase 3 trial will include safety and non-inferiority for the prevention of a composite endpoint of either hospitalization or death from any cause through study day 28.

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