SAB BIO (Nasdaq: SABS) has announced positive topline data from its Phase 1 clinical trial of SAB-142, a novel immunotherapy for type 1 diabetes (T1D). The study, a randomized, double-blind, placebo-controlled, single-ascending dose trial, met its primary objectives related to safety and pharmacodynamic activity, paving the way for a Phase 2b clinical development program in 2025.
The Phase 1 trial evaluated SAB-142 in healthy volunteers and a cohort of participants with T1D. The objectives included establishing the safety, tolerability, pharmacokinetic (PK), immunogenicity, and pharmacodynamic (PD) profile of SAB-142. The topline results indicated that SAB-142 was generally well-tolerated among healthy volunteers, with no reported cases of serum sickness or anti-drug antibodies across the dose range of 0.03 mg/kg to 2.5 mg/kg.
Immunomodulatory Effects
SAB-142 demonstrated sustained immunomodulation with a clinically validated multi-target mechanism of action (MOA). According to SAB BIO, the MOA of SAB-142 was shown to be analogous to rabbit ATG across multiple parameters correlative to C-peptide preservation. C-peptide is a substance produced in the pancreas along with insulin, and its levels can indicate how well the body is producing insulin.
"I am particularly excited with the analysis of the results of our Phase 1 trial, as it marks the successful achievement of another critical milestone for SAB-142," stated Samuel J. Reich, Chairman and CEO of SAB BIO. "These data show clear and positive pharmacologic activity and strong safety profile for SAB-142, and underscore SAB-142's potential to change the lives of people impacted by type 1 diabetes."
Next Steps
Based on the Phase 1 data, SAB BIO plans to advance SAB-142 into a Phase 2b trial in 2025. This trial will evaluate the therapeutic candidate in adult and pediatric patients with new-onset T1D. The company believes that SAB-142 is well-positioned to be a transformative therapy in autoimmunity by delaying the progression or onset of type 1 diabetes.
About SAB-142
SAB-142 is a human anti-thymocyte immunoglobulin (hIgG) developed using SAB BIO's DiversitAb™ platform. This platform utilizes Transchromosomic (Tc) Bovine™ to generate a diverse repertoire of fully human IgGs without the need for human donors or convalescent plasma. SAB-142 aims to modify the course of T1D by delaying onset and potentially preventing disease progression.
