SAB Biotherapeutics announced that the U.S. Food and Drug Administration (FDA) has provided clearance for the Company?s investigational new drug (IND) application to proceed for its phase 1 clinical trial for type 1 diabetes (T1D) therapy SAB-142. SAB is a clinical-stage biopharmaceutical company with a novel immunotherapy platform developing a human anti-thymocyte immunoglobulin (hIgG) 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.

Phase 1 of SAB-142 is a first-in-man study to establish safety, tolerability, pharmacokinetic (PK), immunogenicity, and pharmacodynamic (PD) profile of a human anti-thymocyte biologic SAB-142. The study is designed as a randomized, double-blind, single-ascending dose trial, with a dose range of 0.03mg/kg up to 2.5mg/kg which is a similar dose range studied in the MELD-ATG study, a dose-ranging rabbit ATG study in patients with new onset T1D that will announce its topline result in 2025. Anticipated outcomes include validation of differentiated safety, immunogenicity, and tolerability profile of SAB-142 based on anticipated 0% serum sickness and nAbs.

The study further aims to validate mechanism of action of SAB-142 in humans and establish proof of biological activity. SAB provided a Phase 1 update on April 16, 2024 which noted the third cohort has been fully enrolled and dosed with no observed serum sickness.