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SAB Biotherapeutics Reports NIH is Discontinuing Phase 3 ACTIV-2 Trial Assessing SAB-185 for Treatment of COVID-19 Due to Declining COVID Hospitalizations
NIH is closing enrollment in its ACTIV-2 trial due to low Omicron-related COVID-19 hospitalization and death rates that have made the current study design
About this update from Sab Biotherapeutics, Inc.
[{"type":"text","content":"NIH is closing enrollment in its ACTIV-2 trial due to low Omicron-related COVID-19 hospitalization and death rates that have made the current study design statistically unworkable SAB-185 had advanced into Phase 3 after meeting pre-specified efficacy and safety criteria SAB-185’s targeted, highly potent, fully human polyclonal antibodies have demonstrated neutralization of multiple SARS-CoV-2 variants in vitro, including Delta and Omicron SAB is evaluating future clinical plans for SAB-185 including potential targeted applications such as prophylaxis and treatment in high-risk patient groups SIOUX FALLS, S.D., March 02, 2022 (GLOBE NEWSWIRE) -- SAB Biotherapeutics (SAB) (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 that due to low hospitalization and death rates in the trial, the National Institutes of Health’s (NIH) ACTIV-2 Program is discontinuing enrollment in its Phase 3 COVID-19 trial. SAB-185 was being assessed as part of the Phase 3 ACTIV-2 master protocol evaluating treatments for COVID-19 in patients with mild-moderate infections at higher risk for progression to hospitalization. Reductions in hospitalization and death rates were included as primary endpoints of the Phase 3 trial. However, low hospitalization and death rates recently observed in the study have led the sponsors to conclude that, notwithstanding the potential efficacy of SAB 185, it would not be possible to demonstrate statistically significant clinical efficacy with the existing study design, since so few of the enrolled COVID-19 patients had an observable study endpoint event such as hospitalization. While SAB-185 previously met the initial pre-specified safety and efficacy criteria to continue to the next phase of the Phase 3 ACTIV-2 trial, the independent Data and Safety Monitoring Board (DSMB) recommended that the study be stopped for reasons of “operational futility”, meaning that hospitalization rates had declined to the point where the study was no longer large enough to ensure that statistically significant findings could be obtained. “The NIH-sponsored ACTIV-2 Phase 3 master protocol was designed when previous COVID-19 variants resulted in high infection and hospit...