Biopharmaceutical company SAB Biotherapeutics (SAB) on Saturday provided an update of the interim analysis of the defined safety and efficacy data of SAB-185 in the phase 2 part of the ACTIV-2 study, following an independent Data Safety Monitoring Board (DSMB ) review.

The company said SAB-185 is a fully human, targeted, broadly neutralizing polyclonal antibody drug candidate for the treatment of non-hospitalised patients with mild to moderate COVID-19.

SAB-185 is being tested in the ACTIV-2 study, which is funded and carried out by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the NIH (National Institutes of Health, USA) - in collaboration with the AIDS Clinical Trials Group.

According to the company, the lower and higher doses of SAB-185 tested in phase 2 met the pre-defined efficacy target for transition to phase 3 and were shown to be safe in the interim analysis. The NIAID and SAB researchers are currently in the process of determining the preferred dose for the Phase 3 trial. SAB-185 is being transferred to phase 3 study upon meeting defined promotion criteria.

SAB added that the Phase 3 portion of the ACTIV-2 study is a randomized, open-label, active comparator-controlled, adaptive platform study to evaluate the clinical safety and efficacy of SAB-185 compared to active control treatment with a monoclonal antibody in patients with mild to moderate COVID-19, who have a higher risk of hospitalisation. The primary outcome measured the safety and non-inferiority to prevention of a composite endpoint defined as either hospitalisation or death from any cause by study day 28.