FDA Provides Clearance to IND Application for Type 1 Diabetes Therapy SAB-142 by SAB Biotherapeutics

Core Insights - The U.S. FDA has cleared SAB Biotherapeutics' IND application for SAB-142, a therapy aimed at treating type 1 diabetes (T1D) [1][3] - The ongoing HUMAN trial will generate data for a future Phase 2B trial, focusing on safety, tolerability, pharmacokinetics, and pharmacodynamics of SAB-142 [2][3] Company Overview - SAB Biotherapeutics is a clinical-stage biopharmaceutical company developing human anti-thymocyte immunoglobulin (hIgG) to delay T1D onset or progression [1][7] - The company utilizes advanced genetic engineering to produce high-potency immunoglobulins without the need for human donors or convalescent plasma [7][8] Trial Design - Phase 1 of the SAB-142 trial is a randomized, double-blind, placebo-controlled study with a dose range from 0.03 mg/kg to 2.5 mg/kg [3] - The trial aims to validate the safety and immunogenicity profile of SAB-142, with no observed serum sickness in the third cohort [3][4] Mechanism of Action - SAB-142 is designed to target immune cells that destroy pancreatic beta cells, similar to rabbit anti-thymocyte globulin (ATG), but aims to avoid adverse immune reactions associated with animal-derived treatments [6][4] - Previous clinical trials have shown that rabbit ATG can slow beta cell destruction and preserve insulin production, which is critical for blood sugar regulation [5][6]