SAB Biotherapeutics granted Fast Track designation from FDA for SAB-176

SAB Biotherapeutics announced that the US Food and Drug Administration, FDA, has granted Fast Track designation for SAB-176, an investigational therapeutic for Type A and Type B influenza illness in high-risk patients, including those who have anti-viral resistant strains. SAB also received FDA guidance and regulatory alignment on advancing SAB-176 into the next phase of development through initiation of a Phase 2b dose-range finding efficacy and safety trial in patient populations at high-risk for developing severe disease. SAB-176 is a novel, highly potent immunotherapy that is grounded in fundamentals of the natural immune response to neutralize Type A and Type B influenza viruses, which mutate rapidly. SAB-176 is also being studied in emerging and mutating pandemic strains by targeting multiple epitopes of the virus rather than a single epitope. "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," said Eddie Sullivan, PhD, co-founder, President & CEO of SAB Biotherapeutics. "We are excited about the potential role SAB-176 can play in tackling a highly mutagenic pathogen like influenza." In addition to the Fast Track designation, SAB Biotherapeutics has also received FDA guidance and regulatory alignment on advancing SAB-176 into the next phase of development, including a Phase 2b trial study design.