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SAB Biotherapeutics Announces Positive Results from Phase 3 Trial of SAB-185 in Patients with COVID-19 at High-Risk for Severe Complications
SAB-185, a human IgG1 (polyclonal) antibody therapeutic candidate, demonstrated benefit in sustained symptom resolution in patients with Omicron variants of
About this update from Sab Biotherapeutics, Inc.
[{"type":"text","content":"SAB-185, a human IgG1 (polyclonal) antibody therapeutic candidate, demonstrated benefit in sustained symptom resolution in patients with Omicron variants of SARS-CoV-2\nSIOUX FALLS, S.D., April 26, 2023 (GLOBE NEWSWIRE) -- SAB Biotherapeutics (Nasdaq: SABS), (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human, multi-epitope binding immunoglobulin IgG1 (polyclonal) antibodies without the need for human donors, today announced positive top-line results from the Phase 3 National Institutes of Health’s (NIH) 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®(casirivimab and imdevimab). 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 (p=0.010; Figure 1, Table 1), and the median time to symptom resolution for at least 4 consecutive days was 7 days shorter for SAB-185. Also, the median time to symptom resolution for at least 2 consecutive days was 6 days shorter for SAB-185, as compared to those who were treated with REGEN-COV® (p=0.021; Figure 2, Table 1). In the non-Omicron population, the median time to symptom resolution for at least 4 consecutive days was 7 days shorter for SAB-185, and the median time to symptom resolution for at least 2 consecutive days was 4 days shorter for SAB-185 than REGEN-COV®, though neither of these analyses met statistical significance. Figure 1: Symptom Resolution Over 4 Consecutive DaysFigure 2: Symptom Resolution Over 2 Consecutive Days Source: NIH Table 1: Symptom Resolution for at least 2 days and 4 days Source: NIH 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 ...