SAB Biotherapeutics announces FDA clearance for SAB-142 IND application

SAB Biotherapeutics announced that the U.S. Food and Drug Administration has provided clearance for the Company’s investigational new drug application to proceed for its phase 1 clinical trial for type 1 diabetes therapy SAB-142. SAB is a clinical-stage biopharmaceutical company with a novel immunotherapy platform developing a human anti-thymocyte immunoglobulin for delaying the onset or progression of T1D. The IND allows for enrollment of patients with type 1 diabetes in the United States into the ongoing HUMAN trial designed to generate data enabling an upcoming Phase 2B trial. The HUMAN trial – fully HUman anti-thymocyte biologic in first-in-MAN clinical study – is a phase 1 randomized, double-blind, placebo-controlled, single-ascending dose, adaptive design clinical study designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous SAB-142 in healthy volunteers and participants with T1D.