SAB Biotherapeutics (SAB), a clinical stage biopharmaceutical company developing a novel immunotherapy platform to produce fully human polyclonal antibodies without the need for human donors, announced that the first participant has been dosed in its Phase 1 clinical trial evaluating SAB-176 for the treatment of seasonal influenza. SAB-176 is a novel anti-influenza human immunoglobulin G (IgG) immunotherapy designed to address the limitations of current treatment for severe seasonal influenza. This fully human polyclonal antibody therapeutic targets four influenza virus strains in a way similar to the natural way our bodies fight the disease.
“The initiation of our Phase 1 study of SAB-176 marks a significant milestone for this program developed from our novel technology platform which aims to generate fully-human immunoglobulins without human serum in order to transform the treatment and prevention of a broad range of diseases,” said Eddie J. Sullivan, PhD, President, CEO and Co-Founder of SAB. “SAB-176 is a novel immunotherapy designed to address the unmet need for the treatment of seasonal influenza. SAB-176’s unique properties allow for adaptation to future emerging and mutating seasonal strains, an attribute that has also been shown to be of high importance in other viral diseases, particularly in light of the COVID-19 pandemic and the emerging public health crisis.”
The Phase 1 clinical trial is a randomized, double-blind, single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of SAB-176 delivered intravenously in 27 healthy participants. The study is intended to inform the dosing for Phase 2 including effective dose ranges. Preclinical studies of SAB-176 demonstrated high potency and neutralization against various influenza strains. The healthy volunteer study is expected to be completed in early 2021.