hVIVO plc notes the announcements dated 13 April 2023 and 18 April 2023 from SAB Biotherapeutics reporting that the US Food and Drug Administration has granted Breakthrough Therapy and Fast Track designations for its investigational therapeutic for the treatment of seasonal influenza, SAB-176. hVIVO conducted a Phase 2a human challenge trial to assess the efficacy of SAB-176 using its Influenza Human Challenge Study Model. Both FDA designations are designed to expedite the development and review of medicines that are intended to treat a serious or life-threatening condition.

Breakthrough Therapy designation confers more benefits than Fast Track products and requires that preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over therapies currently available on a clinically significant endpoint(s). A significant portion of the evidence submitted to achieve the designations was data from the successful challenge study conducted by hVIVO. The broad-spectrum efficacy of SAB-176 was demonstrated in Phase 2a human challenge study against an influenza strain that was not specifically targeted in the manufacturing of the therapeutic.

The clinical efficacy data formed an integral part of the package enabling the FDA's decision to grant Fast Track and Breakthrough Therapy designations and underlines the value of rapid efficacy data achievable only through human challenge trials. Validation of a candidate's clinical potential, as well as the expedited review process can be a key inflection point for the asset and company value, particularly for biotechnology clients such as SAB Biotherapeutics.