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SAB Biotherapeutics Reports Positive Phase 2 Virology Data Demonstrating SAB-185 Met Criteria for Advancement to Phase 3 in NIH ACTIV-2 Trial for Treatment of COVID-19
SAB-185 is being evaluated in Phase 3 NIH-Sponsored ACTIV-2 COVID trial of high-risk patients following positive DSMB review of interim Phase 2 safety and
About this update from Sab Biotherapeutics, Inc.
[{"type":"text","content":"SAB-185 is being evaluated in Phase 3 NIH-Sponsored ACTIV-2 COVID trial of high-risk patients following positive DSMB review of interim Phase 2 safety and efficacy data in September More than 700 patients have been enrolled in the Phase 3 trial, exceeding 50% enrollment SAB-185’s targeted, highly potent and fully-human polyclonal antibodies have demonstrated neutralization of SARS-CoV-2 viral variants, including Delta and Omicron SAB-185 was safe and well-tolerated at both doses tested in Phase 2 SIOUX FALLS, S.D., Jan. 24, 2022 (GLOBE NEWSWIRE) -- SAB Biotherapeutics (Nasdaq: SABS), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human polyclonal antibodies without the need for human donors, today reported positive Phase 2 safety and efficacy data demonstrating that SAB-185 met the criteria required for advancement to Phase 3 in the US National Institutes of Health (NIH) COVID-19 ACTIV-2 Trial. SAB-185, a fully-human, specifically targeted, broadly neutralizing polyclonal antibody candidate for the treatment of high-risk non-hospitalized patients with mild to moderate COVID-19, is currently being assessed in the Phase 3 ACTIV-2 trial. It met the criteria for advancement to Phase 3 with Day 3 viral load data from a pre-specified interim data analysis reviewed by the Data Safety Monitoring Board (DSMB) in September. Both the Phase 2 and Phase 3 ACTIV-2 trials are sponsored and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, in collaboration with the AIDS Clinical Trials Group (ACTG). “These positive clinical results from the NIH ACTIV-2 trial are another sign that SAB-185 may have therapeutic potential for the treatment of COVID-19,” said Eddie J. Sullivan, PhD, co-founder, President, and Chief Executive Officer of SAB Biotherapeutics. “SAB-185 appeared safe and achieved a key virologic efficacy criterion, despite a change in protocol early in the study that resulted in enrollment comprised predominantly of patients at low-risk of severe disease. The original protocol focused on high-risk patients, who are most likely to benefit from treatment with SAB-185. Data from a very small subset of high-risk patients treated with SAB-185 showed sharp declines in viral load compared to high-risk placebo c...