SAB Biotherapeutics has dosed the first patient in the Phase III ACTIV-2 clinical trial to evaluate SAB-185, a fully human polyclonal antibody therapeutic to treat Covid-19.
SAB-18 is a broadly neutralising therapeutic candidate developed using SAB’s DiversitAb platform.
The specifically targeted antibody is intended to treat non-hospitalised patients with mild to moderate Covid-19.
Led by the National Institute of Allergy and Infectious Diseases (NIAID), the ACTIV-2 clinical trial is evaluating the multiple investigational agent to treat the early symptomatic non-hospitalised individuals.
The candidate met the pre-defined efficacy goal and progressed from Phase II to the Phase III part of the ACTIV-2 clinical trial.
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It is said to be the first polyclonal antibody therapeutic candidate in the trial and the second agent to advance to Phase III.
SAB Biotherapeutics co-founder, president, and CEO Eddie Sullivan said: “We are delighted that the Phase III trial is underway, just days after the decision by the independent Data Safety Monitoring Board to advance SAB-185 to Phase III.
“The joint decision with NIAID to evaluate the lower dose of SAB-185 in the Phase III 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.”
As part of the randomised, unblinded, active comparator-controlled adaptive platform non-inferiority Phase III study, the company is evaluating SAB-185’s safety and efficacy as against active control monoclonal antibody treatment in Covid-19 patients at higher risk for progression to hospitalisation.
Nearly 600 participants are being enrolled to receive SAB-185 and 600 subjects will be given an active comparator.
Safety and non-inferiority to avoid a composite endpoint of either hospitalisation or death of a subject until study day 28 are included in the trial’s primary outcome measures.