SAB Biotherapeutics has recently announced that the U.S. Food and Drug Administration (FDA) has awarded Breakthrough Therapy Designation (BTD) to their investigational therapeutic, SAB-176.
This designation recognizes the potential of SAB-176 for post-exposure prophylaxis in high-risk patients who are susceptible to Type A and Type B influenza, even including individuals who have strains of the virus that are resistant to antiviral treatments.
SAB-176 is currently undergoing development for various influenza indications, encompassing the treatment of high-risk patient populations, as well as pre-and post-exposure prophylaxis.
The recent Breakthrough Therapy designation from the FDA validates the unique approach of SAB-176, which utilizes a multi-epitope targeting modality. This differentiation sets it apart from monoclonal antibodies (mAb) that only bind to a single epitope.
By employing this novel treatment approach, SAB-176 demonstrates the ability to maintain its efficacy against viral mutations and effectively mitigate the risk of emerging influenza strains that may be resistant to conventional treatments.
The evolution of viruses in response to vaccines or treatments poses a significant challenge. The use of therapeutics can potentially lead to the emergence of "escape mutants," which are virus variants that have undergone changes to evade the pressures exerted by antiviral treatments, including small molecules or monoclonal antibody modalities.
This highlights the importance of developing strategies that can effectively address and overcome the potential development of resistance to viruses.
In the SAB-176-201 clinical trial, clinical evidence demonstrated that SAB-176 significantly reduced the time to resolution of positive viral culture compared to the control group.
Additionally, data from SAB's DiversitAb™ platform indicated that the multi-epitope binding modality of SAB's biologic treatments effectively lowers the risk of the emergence of treatment-resistant viruses.
Furthermore, preclinical evidence showcasing the in vivo efficacy of SAB-176 against treatment-resistant strains further reinforces the scientific basis for the Breakthrough Therapy designation.