The FDA granted breakthrough therapy designation for SAB Biotherapeutics’ (NASDAQ:SABS) SAB-176, an investigational therapeutic, for post-exposure prophylaxis for Type A and Type B influenza illness in high-risk patients, including those who have anti-viral resistant strains.
Earlier this month, SAB received fast track designation from the FDA as well as guidance and regulatory alignment on advancing SAB-176 into a Phase 2b dose-range finding efficacy and safety trial in patient populations at high-risk for developing severe disease.
In a statement, Eddie Sullivan, Ph.D., co-founder, president and CEO of SAB, said the breakthrough designation confirms that the multi-epitope targeting modality of SAB-176 has a clear differentiation, compared with monoclonal antibodies that bind to a single epitope, and SAB’s treatment can sustain its efficacy over viral mutations and prevent or reduce the risk of emerging treatment-resistant influenza strains.
