SAB BIO Announces Positive Confirmatory Clinical Results from the Phase 1 Study of SAB-142 in Development for the Treatment of Stage 3 T1D

Core Insights - SAB Biotherapeutics, Inc. announced positive results from a Phase 1 trial of SAB-142, a treatment for type 1 diabetes (T1D), which has successfully met its primary objectives and is advancing to Phase 2b clinical development [1][7] Group 1: Phase 1 Trial Results - The Phase 1 trial involved 62 healthy volunteers and 6 T1D patients, with doses ranging from 0.03 to 4.5 mg/kg [2] - SAB-142 was well-tolerated, showing a superior safety profile compared to rabbit anti-thymocyte immunoglobulin (rATG), with no cases of serum sickness or adverse events related to anti-drug antibodies [3][7] - No drug-related serious adverse events were reported, with most adverse events being mild and transient, primarily occurring after the first two days of infusion [4] Group 2: Pharmacodynamic Activity - Transient lymphopenia was observed in all subjects post-dosing, which corrected to baseline within 1-3 days, indicating on-target engagement and pharmacodynamic activity [5] - Unlike other immunomodulatory drugs, SAB-142 does not cause sustained lymphodepletion, suggesting it can be safely redosed [5][7] Group 3: Future Development - The Phase 2b SAFEGUARD trial is currently underway, recruiting participants globally to evaluate SAB-142 in both adult and pediatric patients with new-onset, stage 3 T1D [8][9] - The company aims to dose the first patient by the end of the year, indicating a swift progression towards registrational studies [8][9] Group 4: Company Overview - SAB-142 is a multi-specific, fully human anti-thymocyte globulin (hATG) designed to modify the disease course of T1D by targeting immune cells that destroy pancreatic beta cells [10][11] - SAB Biotherapeutics focuses on developing high-potency human immunoglobulin G (hIgG) therapies for immune and autoimmune disorders, utilizing advanced genetic engineering techniques [11]