SAB Biotherapeutics Bags US FDA Nod For Phase 1 Trial of SAB-142

SAB Biotherapeutics, a clinical-stage biopharmaceutical firm, stated that the US Food and Drug Administration (FDA) has approved the company's investigational new drug (IND) application to move on with its phase 1 clinical study for type 1 diabetes (T1D) therapy SAB-142.

SAB is developing a human anti-thymocyte immunoglobulin (hIgG) for the prevention or treatment of type 1 diabetes. The IND authorizes patients with type 1 diabetes in the United States to enroll in the ongoing HUMAN trial, which will collect data for a planned phase 2B trial. 

The HUMAN trial, which stands for 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 evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous SAB-142 in healthy volunteers and T1D participants.

“We are thrilled by FDA’s clearance of our IND for SAB-142, which marks a significant step forward in our mission to slow disease progression in patients with new or recent onset stage 3 type 1 diabetes,” states Samuel J. Reich, chairman and CEO of SAB. “We look forward to expanding our clinical program with SAB-142 as we work to change the lives of people impacted by type 1 diabetes through our unique disease-modifying therapy."