SAB Biotherapeutics’ investigational therapeutic for the treatment of seasonal influenza, SAB-176, has been granted both Breakthrough Therapy and Fast Track designations by the US Food and Drug Administration (FDA).
These designations are aimed at accelerating the development and review process for drugs intended to treat serious or life-threatening conditions, particularly when preliminary clinical evidence suggests that the drug could demonstrate substantial improvement over existing therapies.
Data from hVIVO’s Phase 2a human challenge trial, conducted to evaluate the efficacy of SAB-176 using its Influenza Human Challenge Study Model, played a significant role in the FDA’s decisions. The trial showed that SAB-176 offers broad cross-protection against different strains of influenza, including those not specifically targeted in the original manufacturing of the therapeutic.
hVIVO, a specialist contract research organization (CRO) with expertise in testing infectious and respiratory disease products using human challenge clinical trials, has over three decades of experience in safely conducting challenge studies across a range of respiratory viruses, including various strains of influenza, respiratory syncytial virus (RSV), human rhinovirus (HRV), COVID-19, asthma, and malaria.
According to Alex Mann, Senior Director of Clinical Science of hVIVO, the clinical efficacy data from the Phase 2a human challenge study formed an essential part of the package that enabled the FDA’s decision to grant Fast Track and Breakthrough Therapy designations. He also emphasized the value of human challenge trials in providing rapid efficacy data and validating a candidate’s clinical potential.
