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SAB Biotherapeutics (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human polyclonal antibodies, today announced that the first participant has been dosed in its Phase 2a clinical trial evaluating the safety and efficacy of SAB-176 in a human challenge study. SAB-176 is a novel anti-influenza human immunoglobulin G (IgG) immunotherapy designed to address the limitations of current treatments for moderate to severe seasonal influenza. It is a high-potency multivalent human polyclonal antibody therapeutic designed specifically to treat or prevent Type A and Type B seasonal and pandemic influenza virus infections.
“With the devastating health and economic impacts of seasonal influenza and hundreds of thousands of hospitalizations and deaths annually, more effective therapies for moderate to severe cases are needed. We are excited to be advancing SAB-176, a novel high-potency immunotherapy with the unique ability to simultaneously target Type A and B influenza, including emerging and mutating strains,” said Eddie J. Sullivan, PhD, co-founder, president and CEO of SAB Biotherapeutics. “SAB-176 has the potential to complement seasonal vaccine programs, to achieve better efficacy than small molecule anti-influenza antivirals in the general population, and to serve as a valuable prophylactic in high-risk populations. We look forward to progressing this promising therapy, which harnesses the unique attributes of our fully-human polyclonal antibody platform, to address highly-mutating viruses that have significant annual health impacts as well as pandemic potential.”
The Phase 2a trial is a randomized, double-blind, placebo-controlled study that will evaluate the safety and treatment efficacy of SAB-176 in 60 healthy adults challenged with a pandemic influenza virus strain (pH1N1). For more information on the study, visit clinicaltrials.gov (Identifier: NCT04850898). SAB-176 is also being evaluated in an ascending dose, double-blind, randomized, placebo-controlled Phase 1 safety trial in healthy volunteers. SAB expects to report data from this study in the fourth quarter of 2021.
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