SAB BIOTHERAPEUTICS INC Stock Price, News & Analysis

SAB Biotherapeutics announced positive top-line results from the Phase 3 NIH ACTIV-2 clinical trial evaluating SAB-185, a human IgG1 antibody therapeutic candidate, in non-hospitalized COVID-19 patients at high risk of severe outcomes. The trial found that 66% of participants receiving SAB-185 achieved full symptom resolution for at least four consecutive days by Day 28, compared to 50% for the REGEN-COV® group (p=0.010). Furthermore, the median time to symptom resolution was significantly shorter for SAB-185, with a reduction of 7 days for 4-day resolution and 6 days for 2-day resolution. However, the primary endpoint regarding hospitalizations and deaths was inconclusive due to the low number of clinical events following the emergence of the Omicron variant. The trial was halted based on recommendations from the Data and Safety Monitoring Board.

SAB Biotherapeutics announced that its investigational therapeutic, SAB-176, has received both Breakthrough Therapy and Fast Track designations from the FDA for treating high-risk patients and post-exposure prophylaxis of Type A and B influenza. This dual designation could significantly expedite its development and regulatory process. SAB-176, a fully-human multi-epitope binding antibody, shows promise against antiviral-resistant strains of influenza. The company is poised to initiate a Phase 2b trial after receiving FDA guidance, highlighting its clear regulatory pathway for further development. The therapy aims to offer broad protection against evolving influenza strains, potentially addressing significant health concerns globally.

SAB Biotherapeutics has announced the FDA granting Fast Track designation for SAB-176, an investigational immunotherapy for treating Type A and Type B influenza in high-risk patients. This therapeutic approach is significant as it produces fully-human antibodies without needing human donors, utilizing the proprietary DiversitAb™ platform. The FDA's approval facilitates the advancement into a Phase 2b trial to evaluate the safety and efficacy of SAB-176, particularly among patients with antiviral-resistant influenza strains. This innovative therapy aims to provide broad protection against rapidly mutating influenza viruses, responding to the global health challenges posed by seasonal and pandemic influenza.