April 14, 2023

The U.S. Food and Drug Administration has cleared Sioux Falls-based SAB Biotherapeutics to move ahead with “fast track designation” for its therapeutic showing promising results in treating influenza.

The therapeutic known as SAB-176 has gone through phase one clinical trials showing its safety and part of phase two, which showed “broad antibody protection against multiple strains of this rapidly mutating virus,” including “broad cross protection that included strains that were not specifically targeted in the manufacturing of the therapeutic,” the company said in a statement.

The company now can initiate a Phase2b dose-range-finding efficacy and safety trial in patients who are at high risk for developing severe disease.

“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, co-founder, president and CEO of SAB Biotherapeutics. “We are excited about the potential role SAB-176 can play in tackling a highly mutagenic pathogen like influenza.”

 The fast track designation is designed to facilitate 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.

SAB-176 is a novel, highly potent immunotherapy that uses the company’s unique platform technology to neutralize Type A and Type B influenza viruses, which mutate rapidly.

The study will evaluate the safety and efficacy of SAB-176 in high-risk patients with Type A or Type B influenza illness, including those who have anti-viral treatment-resistant strains. In addition, the FDA aligned with SAB’s manufacturing approach, which includes a plasma pooling strategy allowing hyperimmunization to address multiple strains of influenza on an annual basis. This paves the way for SAB to address strain changes, similar to how seasonal influenza vaccines are developed, the company said.

“SAB-176 has the potential to be a game-changer in the fight against influenza,” said Dr. Alexandra Kropotova, chief medical officer of SAB Biotherapeutics. “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. We see this fast track designation as a testament to the promise of our innovative DiversitAb platform, which is equipped to rapidly respond to mutating infectious diseases like influenza.”

The CDC estimates that there 9 million to 41 million cases of influenza each year in the U.S., with 140,000 to 710,000 hospitalizations and 12,000 to 52,000 deaths per year. While Tamiflu is an effective therapy for treating influenza if used within two days of symptom onset, some patients still develop severe disease, and resistant strains of influenza to anti-viral drugs have increased in recent years. SAB-176 offers the potential for an additional treatment for influenza, particularly in higher-risk patients, the company said.

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