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

The FDA has granted Fast Track designation for SAB Biotherapeutics' (NASDAQ: 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 (OTC: 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.

Don't miss real-time alerts on your stocks - join Benzinga Pro for free! Try the tool that will help you invest smarter, faster, and better.

This article EXCLUSIVE: FDA Grants Expedited Review Status To SAB Biotherapeutics' Influenza Antibody originally appeared on Benzinga.com

.

© 2023 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.