SAB Biotherapeutics announces results from Phase 3 trial of SAB-185

SAB Biotherapeutics announced positive top-line results from the Phase 3 National Institutes of Health’s ACTIV-2 clinical trial that assessed SAB-185 in non-hospitalized people with COVID-19 who were at high risk for severe outcomes. Trial data show that SAB-185 demonstrated benefit in sustained symptom resolution in study participants with COVID-19 caused by Omicron as compared to participants who received a monoclonal antibody combination, REGEN-COV. Specifically, 66% of participants treated with SAB-185 reached full symptom resolution for at least 4 consecutive days by Day 28, while only 50% of participants on REGEN-COV met this endpoint, and the median time to symptom resolution for at least 4 consecutive days was 7 days shorter for SAB-185. The primary endpoint of the study was the composite of all-cause hospitalizations and deaths. Following the emergence of the Omicron variant in late 2021, the number of these clinical events dropped significantly. An interim review conducted by the study’s Data and Safety Monitoring Board determined that there would not be enough clinical events in this study, with the number of participants specified in the protocol, to arrive at a conclusive result, and the trial was halted. "The ACTIV-2 data is further validation of the potential of SAB’s platform," said Eddie Sullivan, Ph.D., co-founder, President, and Chief Executive Officer of SAB Biotherapeutics. "It shows that the DiversitAb(TM) platform can open the door to treatments that are potentially more effective and potent and which remain efficacious over longer periods of time versus monoclonal antibodies. This is not surprising, as SAB-185 has been shown to have pseudovirus neutralizing activity1,2 and protection in animal models ranging from Alpha to Omicron variants3."