SAB BIO Announces Positive Topline Phase 1 Clinical Results with Potentially Disease-Modifying T1D Therapy SAB-142

Core Insights - SAB BIO announced positive topline data from a Phase 1 trial of SAB-142, which met its primary objectives related to safety and pharmacodynamic activity, allowing it to advance to Phase 2b clinical development [1][2][3] Company Overview - SAB BIO is a clinical-stage biopharmaceutical company focused on developing human, multi-targeted, high-potency immunoglobulins (IgGs) to treat and prevent immune and autoimmune disorders, specifically targeting type 1 diabetes (T1D) with its lead asset, SAB-142 [9] Phase 1 Trial Summary - The Phase 1 trial was a randomized, double-blind, placebo-controlled study among healthy volunteers and participants with T1D, aimed at establishing safety, tolerability, pharmacokinetic, immunogenicity, and pharmacodynamic profiles for SAB-142 [3][4] - The trial demonstrated that SAB-142 was generally well-tolerated, with no reported serum sickness or anti-drug antibodies at the target dose [6][7] Safety and Efficacy - SAB-142 exhibited a favorable safety profile, supporting chronic dosing in an outpatient setting, with a dose range from 0.03 mg/kg to 2.5 mg/kg [7] - The mechanism of action (MoA) of SAB-142 was shown to be analogous to rabbit ATG, with sustained immunomodulation and clinically validated multi-target mechanisms [7] Future Development Plans - Based on the positive data, SAB BIO plans to advance SAB-142 into a Phase 2b trial in 2025 to evaluate its therapeutic potential in adult and pediatric patients with new-onset T1D [4][6]