EXCLUSIVE: SAB Biotherapeutics Secures FDA Breakthrough Therapy Tag For Its Influenza Immunotherapy

The FDA has granted Breakthrough Therapy Designation (BTD) to SAB Biotherapeutics Inc's (NASDAQ: SABS) SAB-176, an investigational therapy for post-exposure prophylaxis for Type A and Type B influenza illness in high-risk patients, including antiviral resistant strains. 

What Happened: SAB-176 is being developed for several influenza indications, including treating high-risk patient populations and pre-and post-exposure prophylaxis. 

The company says its influenza therapeutic is now eligible for intensive guidance from FDA for an efficient development program.

Last week, the FDA granted Fast Track designation to SAB-176.

The company also received FDA guidance and regulatory alignment on advancing SAB-176 into a Phase 2b dose-range, finding efficacy and safety trial in patient populations at high risk for developing severe diseases.

Why It Matters: The FDA's Breakthrough Therapy designation confirms that the multi-epitope targeting modality of SAB-176 has a clear differentiation vs. monoclonal antibodies (mAb) that bind to a single epitope. 

SAB's treatment can sustain its efficacy over viral mutations and prevent or reduce the risk of emerging treatment-resistant influenza strains. 

Clinical evidence for SAB-176 generated in the SAB-176-201 clinical trial showed a significantly shorter resolution of positive viral culture than the control group. 

SAB's DiversitAb platform data also showed that the multi-epitope binding modality of SAB's biologic treatments reduces the risk for the emergence of treatment-resistant viruses. 

Preclinical evidence of in vivo efficacy of SAB-176 in treatment-resistant strains further supports the scientific foundation for this Breakthrough designation. 

Price Action: SABS shares closed at $0.74 on Monday.