SIOUX FALLS, S.D.– SAB Biotherapeutics (SAB), 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 announced that the first patient has been dosed with SAB-185 in the Phase 3 ACTIV-2 COVID-19 trial.
SAB-185 is a fully human, specifically targeted, broadly neutralizing polyclonal antibody therapeutic candidate for the treatment of non-hospitalized patients with mild to moderate COVID-19. The candidate is being assessed in the ACTIV-2 trial led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH) in collaboration with the AIDS Clinical Trials Group.
SAB-185 is the second agent to graduate to Phase 3 and the first polyclonal antibody therapeutic candidate in ACTIV-2, which is evaluating multiple investigational agents to treat early symptomatic COVID-19 in non-hospitalized individuals.
SAB-185 advanced from Phase 2 to the Phase 3 portion of the ACTIV-2 trial based on meeting pre-defined graduation criteria. The interim analysis demonstrated that both the lower and higher doses of SAB-185 tested in Phase 2 met the pre-defined efficacy goal for advancement to Phase 3 and appeared safe. SAB researchers in consultation with NIAID have determined the lower dose of SAB-185 (3,840 Units/kg) will be assessed in Phase 3.
“We are delighted that the Phase 3 trial is underway, just days after the decision by the independent Data Safety Monitoring Board to advance SAB-185 to Phase 3,” said Eddie J. Sullivan, PhD, co-Founder, President, and Chief Executive Officer of SAB Biotherapeutics. “The joint decision with NIAID to evaluate the lower dose of SAB-185 in the Phase 3 trial is a testament to the potency of our human polyclonal antibody therapeutic candidate, which has demonstrated neutralization of multiple emerging SARS-CoV-2 variants in recently published nonclinical studies.”
The Phase 3 portion of the ACTIV-2 trial is a randomized, unblinded, active comparator-controlled adaptive platform non-inferiority study that is assessing 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. It is 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 include safety and non-inferiority for the prevention of a composite endpoint of either hospitalization or death from any cause through study day 28.
