The US-based clinical-stage biopharmaceutical company had recently launched a phase 1 trial for SAB-185 in healthy volunteers to evaluate its safety.
Apart from its potential treatment of Covid-19, the drug candidate can give protective antibodies that can have substantial value in giving protection against the SARS-CoV-2 virus to front-line responders, mission-critical staff, military, and high-risk populations, as per the company.
Its phase 1b study will be a randomised, double-blind, ascending dose trial, which will see the human polyclonal antibody therapeutic administered to the patients intravenously. A total of 21 patients with mild or moderate Covid-19 are taking part in the early-stage trial whose primary endpoint is safety.
The secondary endpoints of the phase 1b trial will include assessment of the course of mild and moderate Covid-19 infection in patients who are not completely bed-ridden.
The phase 1b trial will be undertaken at Sanford Health in Sioux Falls, South Dakota, and across multiple other sites, said SAB Biotherapeutics.
The company plans to use the data from the two trials for determining the dosing and design of the follow-up phase 2 safety and efficacy studies of the human polyclonal antibody therapeutic.
SAB Biotherapeutics co-founder, president and CEO Eddie Sullivan said: “We believe that SAB-185 has the potential to be a differentiated treatment option that provides a highly-specific match against the complexity, diversity, and mutations of SARS-CoV-2.
“Dosing the first patient in this study marks a major milestone for us as we continue to advance our robust COVID-19 program and represents a step forward in the fight against the ongoing global health crisis.”
SAB-185 is said to have been created from a subunit of the SARS-CoV-2 Wuhan strain by using the company’s DiversitAb Rapid Response Antibody Program. During preclinical studies, the investigational Covid-19 therapy is said to have neutralised both the Munich and the Washington strains.
Both the phase 1 and phase 1b trials of the Covid-19 therapeutic candidate are directly supported by the US government.
In July 2020, SAB Biotherapeutics secured $14m in a Series B funding round from the likes of pharma major Merck and others.