Innovative Influenza Therapeutic Awarded Fast-Track Status

SAB Biotherapeutics today announced that the U.S. Food and Drug Administration (FDA) had 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-176 offers the potential for additional treatment for influenza, particularly in higher-risk patients.

SAB also received FDA guidance and regulatory alignment on advancing SAB-176 into the next development phase by initiating a Phase 2b dose-range finding efficacy and safety trial in high-risk patients for developing severe disease.

SAB-176 is a novel, highly potent immunotherapy grounded in the fundamentals of the natural immune response to neutralize Type A and Type B influenza viruses, which mutate rapidly.

SAB-176 has undergone multiple clinical and pre-clinical studies, including a Phase 1 trial in healthy volunteers and a Phase 2a challenge study completed last year.

In the Phase 2a study, SAB-176 showed broad cross-protection that included influenza strains not explicitly targeted in manufacturing the therapeutic.

"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 continuingly, with an excessively high number of hospitalizations and deaths each year," said Eddie Sullivan, Ph.D., co-founder, President & CEO of SAB Biotherapeutics, in a press release on April 13, 2023.

"We are excited about the potential role SAB-176 can play in tackling a highly mutagenic pathogen like influenza."

SAB-176 is also being studied in emerging and mutating pandemic strains by targeting multiple epitopes of the virus rather than a single epitope. 

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. 

Throughout the 2022-2023 flu season in the U.S., over 171 million influenza vaccines were distributed, which remain available at health clinics and pharmacies.