SAB Biotherapeutics Receives FDA Fast Track Designation for Influenza Immunotherapy
The FDA has granted Fast Track Designation to SAB Biotherapeutics (Nasdaq: SABS) for its investigational therapeutic for Type A and Type B influenza illness in high-risk patients.
The company believes that its lead candidate, SAB-176, has the potential to be a superior therapeutic to achieve and sustain efficacy against influenza, which results in 12,000-52,000 deaths per year in the US.
The company’s shares soared nearly 90% in trading following the announcement.
Data from SAB’s Phase 1 and 2 clinical trials indicate that SAB-176 offers broad antibody protection against multiple strains of the influenza virus, including strains that were not specifically targeted in the manufacturing of the therapeutic.
SAB has also received FDA guidance regarding advancing a Phase 2b clinical trial for SAB-176 to evaluate safety and efficacy in high-risk patients with Type A or Type B influenza illness, including those who have antiviral treatment resistant strains.
SAB’s treatment is produced using the company’s proprietary DiversitAb™ platform, which enables rapid production of human polyclonal IgG antibodies without the need for human donors.
The FDA’s Fast Track designation facilitates accelerated development and expedited review of medicines that treat critical illnesses and address an unmet medical need, with the goal of having promising treatments reaching approval and patients as quickly as possible.
About SAB Biotherapeutics
SAB Biotherapeutics, Inc. (SAB) is a clinical-stage biopharmaceutical company developing immunotherapeutic antibodies to treat and prevent infectious diseases and immune and autoimmune disorders. The company’s development programs include infectious diseases resulting from outbreaks and pandemics, as well as immunological, gastroenterological, and respiratory diseases that have significant mortality and health impacts on immune-compromised patients. SAB currently has multiple drug development programs underway and collaborations with the US government and global pharmaceutical companies.