Therapy Areas: Diabetes
SAB Biotherapeutics Doses First Participant in Phase 2a Trial of SAB-176 for the Treatment of Influenza
29 June 2021 - - 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, US-based biopharmaceutical company SAB Biotherapeutics said.

SAB-176 is a novel anti-influenza human immunoglobulin G 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.

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).

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.

SAB-176 is a multivalent, broadly neutralizing fully-human polyclonal antibody therapeutic candidate in development for the treatment, or prevention, of severe influenza.

The novel, specifically-targeted therapeutic leverages the natural human biological immune response to specifically bind to Type A and Type B influenza viruses.

It can also be modified to address annual strain changes when needed. Preclinical data suggests that SAB-176 offers broad protection against diverse influenza strains.

According to the US Centers for Disease Control, on average about 8% of the US population gets sick from flu each season and between 12,000 and 61,000 infected Americans die, depending on the severity of the season.

In 2019-2020, considered a moderate flu season, 38m people in the US became ill with the flu, 18 m saw a healthcare provider for treatment, 400,000 were hospitalized and an estimated 22,000 died.

Globally, there are between 2.5 and 5m influenza-related hospitalizations per year.

The CDC recommends an annual flu shot for almost everyone over the age of six months, but each year less than half the population is vaccinated.

In addition, because influenza viruses are highly mutating, the vaccines have varying levels of protection in any year, but rarely exceed 50% protection. Young children, the elderly, immune-compromised individuals and patients with chronic health conditions are especially at risk of poor outcomes from influenza.

SAB Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company advancing a new class of immunotherapies based on its human polyclonal antibodies.

SAB has applied advanced genetic engineering and antibody science to develop transchromosomic Bovine herds that produce fully-human antibodies targeted at specific diseases, including infectious diseases such as COVID-19 and influenza, immune system disorders including type 1 diabetes and organ transplantation, and cancer.

SAB's versatile and scalable DiversitAb platform is applicable to a wide range of serious unmet needs in human diseases.

It rapidly produces natural, specifically-targeted, high-potency, human polyclonal immunotherapies at commercial scale.

SAB is currently advancing multiple clinical programs and has a number of collaborations with the US government and global pharmaceutical companies.

On June 22, 2021, SAB announced a planned merger with Big Cypress acquisition Corp. (NASDAQ: BCYP), The transaction is expected to close in 4Q21.