SIOUX FALLS, S.D.– SAB Biotherapeutics (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human polyclonal antibodies without the need for human donors, today announced the completion of enrollment in its Phase 2a clinical trial evaluating the safety and efficacy of SAB-176 in a challenge study. SAB-176 is a novel anti-influenza human 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, including emerging and mutating strains.
“Achieving full enrollment in the Phase 2a study of SAB-176 marks a milestone in advancing our growing clinical pipeline and reflects progress toward our goal of successfully developing our unique therapeutic candidate, which has demonstrated the potential to overcome key limitations of previous and current treatments for seasonal influenza,” said Eddie J. Sullivan, PhD, co-Founder, President, and Chief Executive Officer of SAB Biotherapeutics. “These include its ability to simultaneously target Type A and B influenza, including emerging and mutating strains, to potentially offer a more effective treatment option than current antivirals, and to provide additional prophylaxis protection for high-risk populations. The recent surge of COVID-19 cases worldwide highlights the importance of addressing other highly-mutating viruses like influenza that may exacerbate the impact of pandemics.”
The Phase 2a clinical trial is a randomized, double-blind, placebo-controlled study that is evaluating the safety and treatment efficacy of SAB-176 in 60 healthy adults challenged with a pandemic influenza virus strain (pH1N1). The primary endpoint of the study is viral load of subjects treated with SAB-176 compared to placebo at 28 days as measured by qRT-PCR nasal samples. For more information on the study, visit clinicaltrials.gov (Identifier: NCT04850898).
SAB-176 is also currently being evaluated in a Phase 1 ascending dose, double-blind, randomized, placebo-controlled safety trial in healthy volunteers, which has also completed enrollment.
On June 22, 2021, SAB announced a planned merger with Big Cypress Acquisition Corp. (NASDAQ: BCYP). The transaction is expected to close in the fourth quarter of 2021.