regulatory
confidence high
sentiment positive
materiality 0.85
FDA clears IND for SAB Biotherapeutics' T1D therapy SAB-142 Phase 1 trial
SAB Biotherapeutics, Inc.
- FDA cleared IND for SAB-142, a human anti-thymocyte immunoglobulin for type 1 diabetes.
- Phase 1 HUMAN trial is randomized, double-blind, placebo-controlled, single-ascending dose (0.03-2.5 mg/kg).
- Enrollment of US patients with type 1 diabetes now permitted; third cohort dosed with no serum sickness.
- Topline results from the MELD-ATG study expected in 2025.
- SAB-142 aims to delay onset or progression of stage 3 type 1 diabetes.