The FDA has also provided guidance and regulatory alignment to advance SAB-176 into the next phase of development, including a phase 2b trial study design
SAB-176 is an investigational novel, highly potent, neutralising polyclonal immunoglobulin antibody therapy. (Credit: CDC on Unsplash)
SAB Biotherapeutics has received the US Food and Drug Administration (FDA) Fast Track designation for its SAB-176 therapeutic to treat type A and type B influenza illness in high-risk patients, including those with anti-viral resistant strains.
SAB-176 is an investigational novel, highly potent, neutralising polyclonal immunoglobulin antibody therapy.
The therapy is aimed to prevent or reduce severe outcomes of influenza infection in patients at high risk for severe complications, including immunocompromised individuals.
The FDA has also provided guidance and regulatory alignment to advance SAB-176 into the next phase of development, including a Phase 2b trial study design.
SAB will now initiate a Phase 2b dose range finding efficacy and safety trial in patients at high risk of acquiring severe diseases.
Currently, SAB-176 is being assessed in emerging and mutating pandemic strains by targeting multiple epitopes of the virus rather than a single epitope.
The investigational therapy is developed using SAB’s proprietary DiversitAb platform. It allows rapid, scalable production of potent, fully-human polyclonal IgG antibodies, without needing human donors.
SAB Biotherapeutics president and CEO Eddie Sullivan said: “We are pleased to receive the FDA Fast Track designation for SAB-176. Influenza continues to be one of the biggest public health challenges the world faces on a continuing basis, with an excessively high number of hospitalizations and deaths each year.
“We are excited about the potential role SAB-176 can play in tackling a highly mutagenic pathogen like influenza.”
The influenza immunotherapy has undergone many clinical and pre-clinical studies, including a Phase 1 trial in healthy volunteers and a Phase 2a challenge study that was completed last year.
As per the findings, SAB-176 provides broad antibody protection against multiple strains of this rapidly mutating virus.
In the Phase 2a study, the investigational therapy demonstrated broad cross-protection including strains that were not targeted in the manufacturing of the therapeutic.
The upcoming Phase 2b trial will evaluate the safety and efficacy of SAB-176 in high-risk patients with Type A or Type B influenza illness, according to the biopharmaceutical company.