EXCLUSIVE: FDA Grants Expedited Review Status To SAB Biotherapeutics' Influenza Antibody

The FDA has granted Fast Track designation for SAB Biotherapeutics' SABS 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.

What Happened: SAB-176 is produced using SAB's proprietary DiversitAb platform, which enables rapid, scalable production of highly potent, fully-human polyclonal IgG antibodies without human donors.

Data from previously completed trials indicate that SAB-176 offers broad antibody protection against multiple strains of this rapidly mutating virus.

Also Read: EXCLUSIVE: SAB Biotherapeutics Says Influenza, COVID-19 Candidates Showing Broad Efficacy Against Variants.

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

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.

Why It Matters: The CDC estimates an average of 9 to 41 million cases of influenza each year in the U.S., with 140,000-710,000 hospitalizations and 12,000-52,000 deaths per year.

While Roche Holdings AG's RHHBY Tamiflu (oseltamivir) 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 has increased in recent years.

SAB Biotherapeutics says that SAB-176 offers the potential for additional treatment for influenza, particularly in higher-risk patients.

In January, SAB Biotherapeutics received an additional $8.2 million from the U.S. Department of Defense related to the closeout of the discontinued COVID-19 prototype R&D contract.

Price Action: SABS shares closed at $0.38 on Wednesday.