SAB Biotherapeutics (NASDAQ:SABS) announced on Thursday that the US Food and Drug Administration (FDA) has granted Fast Track designation for its investigational therapeutic SAB-176 for Type A and Type B influenza illness in high-risk patients, including those who have anti-viral resistant strains, causing the company's shares to shoot up more than 80%.
A Fast Track designation allows drugmakers to expedite the development and review of medicines that target critical illnesses and address unmet medical needs.
SAB said in a statement that along with the Fast Track designation, it received FDA guidance and regulatory alignment for advancing SAB-176 into the next phase of development through the initiation of a Phase 2b dose-range finding efficacy and safety trial in patient populations at high risk for developing severe disease.
The investigational therapeutic has undergone multiple clinical and pre-clinical studies, including a Phase 1 trial in healthy volunteers and a Phase 2a challenge study, with data indicating that SAB-176 offers broad antibody protection against multiple strains of this rapidly mutating virus, SAB reported.
"SAB-176 has the potential to be a game-changer in the fight against influenza," said Dr Alexandra Kropotova, SAB’s chief medical officer.
"Its multi-pronged mechanism of action, long half-life, and low risk of emergence of resistant strains could make it a superior therapeutic to achieve and sustain efficacy against this ever-evolving virus.”
SAB’s shares had jumped 80.8% to US$0.69 shortly after noon in New York.
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