FDA Provides Clearance to IND Application for Type 1 Diabetes Therapy SAB-142 by SAB Biotherapeutics
MIAMI, May 21, 2024 (GLOBE NEWSWIRE) -- SAB Biotherapeutics (Nasdaq: SABS) (the “Company” or “SAB”), today 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.
- MIAMI, May 21, 2024 (GLOBE NEWSWIRE) -- SAB Biotherapeutics (Nasdaq: SABS) (the “Company” or “SAB”), today 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.
- Anticipated outcomes include validation of differentiated safety, immunogenicity, and tolerability profile of SAB-142 based on anticipated 0% serum sickness and nAbs.