SAB Biotherapeutics, Inc. announced that the first participants of aHUMAN trial (Fully HUman anti-thymocyte biologic in first-in-MAN clinical study) have been dosed in Australia. This Phase 1 randomized, double-blind, placebo-controlled, single-ascending dose, adaptive design clinical study was designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous SAB-142 in healthy volunteers and participants with T1D. SAB-142 is a first-in-class fully-human anti-thymocyte immunoglobulin being developed as a disease-modifying treatment to delay the onset and progression of T1D.

In October 2023, SAB received approval by the Australian Human Research Ethics Committee (HREC) to commence the Phase 1 clinical trial investigating safety, tolerability, pharmacodynamic, and immunogenicity of SAB-142. The primary objective of the trial is two-fold: 1) to generate data on differentiated safety and immunogenicity of this fully-human immunoglobulin, and 2) to establish a Proof of Biological Activity (POBA) for SAB-142. Those immunological effects have been previously elucidated in efficacy trials in T1D patients with rabbit-derived anti-thymocyte globulin (ATG).

More information about the Phase 1 clinical trial with SAB-142 can be found here. The program is expected to rapidly expand globally, subject to regulatory approvals in the United States, United Kingdom and European Union countries. SAB is on track to file an Investigational New Drug (IND) application for SAB-142 with the U.S. Food and Drug Administration (FDA) in 2024, along with filings in UK and EU countries to enable efficient progress towards the Phase 2b development.

SAB-142 is a fully-human alternative to rabbit anti-thymocyte glob insulin (ATG). SAB-142's mechanism of action is similar to that of rabbit ATG, which has been clinically validated in multiple clinical trials for type 1 diabetes, demonstrating the ability to slow down disease progression in patients with new or recent onset of Stage 3 type 1 diabetes. Two clinical trials have shown that a single, low dose of rabbit ATG has demonstrated the ability to modulate the body's immune response to help slow beta cell destruction and preserve the ability of these cells to generate insulin, which the body needs to regulate blood sugar and carry out all human activities.

SAB-142, like rabbit ATG, directly targets multiple immune cells involved in destroying pancreatic beta cells.