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SAB Biotherapeutics has dosed the first patient in a Phase Ib clinical trial of its human polyclonal antibody therapeutic, SAB-185, against Covid-19.
Based on the company’s DiversitAb platform, SAB-185 is designed to neutralise live SARS-CoV-2 at titers compared to convalescent plasma. DiversitAb leverages the human immune response to generate human polyclonal antibodies.
The company used a new approach to develop the immunotherapy against Covid-19.
This approach involves genetically engineered cattle to generate fully human antibodies. It is said to facilitate a scalable manufacturing of a targeted, high potency neutralising antibody.
The randomised, double-blind, ascending dose of the Phase Ib trial will assess the safety and pharmacological activity of intravenous in 21 mild or moderate Covid-19 patients.
The primary endpoint of the trial is safety, while the secondary endpoints include an assessment of the course of mild and moderate form of the disease in ambulatory patients.
SAB-185 is also being evaluated in a Phase I trial in healthy participants.
Data from the Phase I and Phase Ib trials is expected to help in informing the dosing and design of future Phase II safety and efficacy trials.
SAB Biotherapeutics said that the Phase Ib Covid-19 trial is set to be performed at several sites, including Sanford Health in Sioux Falls, South Dakota, US.
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.
“The speed with which we have advanced our programme reflects our deep understanding of human polyclonal antibodies, the pressing need for treatment options, and the commitment of our team to develop a novel class of immunotherapies that is designed to establish a responsive model for health crises.”
The Phase Ib study is expected to be completed in December this year.