Business
SAB Biotherapeutics Announces Commencement of the HUMAN Phase 1 Clinical Trial with SAB-142, a Potential Disease-Modifying Treatment for Type 1 Diabetes
First subject has been dosed in the first-in-man Phase 1 clinical study of SAB-142, the first fully-human anti-thymocyte immunoglobulin (ATG) SAB-142 directly
About this update from Sab Biotherapeutics, Inc.
[{"type":"text","content":"First subject has been dosed in the first-in-man Phase 1 clinical study of SAB-142, the first fully-human anti-thymocyte immunoglobulin (ATG) SAB-142 directly and specifically targets multiple immune cells involved in the destruction of insulin-producing pancreatic beta cells to potentially preserve beta cell function SAB Biotherapeutics is pursuing IND and CTA filings with U.S. FDA and EMA in 2024 to clinically advance development of SAB-142 into Phase 2b study SIOUX FALLS, S.D., Nov. 29, 2023 (GLOBE NEWSWIRE) -- SAB Biotherapeutics, Inc. (Nasdaq: SABS), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that is developing fully-human anti-thymocyte immunoglobulin (hIgG) for disease-modification of Type 1 Diabetes (T1D) through delaying the onset and/or progression of the disease, today announced that the first participants of a HUMAN trial (Fully HUman anti-thymocyte biologic in first-in-MAN clinical study) have been dosed in Australia. This Phase 1 randomized, double-blind, placebo-controlled, single-ascending dose, adaptive design clinical study was designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous SAB-142 in healthy volunteers and participants with T1D. SAB-142 is a first-in-class fully-human anti-thymocyte immunoglobulin being developed as a disease-modifying treatment to delay the onset and progression of T1D. In October 2023, SAB received approval by the Australian Human Research Ethics Committee (HREC) to commence the Phase 1 clinical trial investigating safety, tolerability, pharmacokinetic, pharmacodynamic, and immunogenicity of SAB-142. The primary objective of the trial is two-fold: 1) to generate data on differentiated safety and immunogenicity of this fully-human immunoglobulin, and 2) to establish a Proof of Biological Activity (POBA) for SAB-142. Establishing POBA will focus on validating the immunological effects associated with an anti-thymoglobulin mechanism of action in modulating autoimmune response associated with progression of T1D. Those immunological effects have been previously elucidated in efficacy trials in T1D patients with rabbit-derived anti-thymocyte globulin (ATG). More information about the Phase 1 clinical trial with SAB-142 (ACTRN:12623001089628) can be found here. “This marks an important milestone in our developmen...