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SAB Biotherapeutics Receives Australian Approval to Commence Phase 1 Clinical Trial of SAB-142, a Potential Disease-Modifying Treatment for Type 1 Diabetes
Australian Human Research Ethics Committee (HREC) grants approval for SAB to begin first-in-human Phase 1 clinical study of SAB-142, the first fully human
About this update from Sab Biotherapeutics, Inc.
[{"type":"text","content":"Australian Human Research Ethics Committee (HREC) grants approval for SAB to begin first-in-human Phase 1 clinical study of SAB-142, the first fully human anti-thymocyte immunoglobulin (ATG) SAB-142 directly targets multiple immune cells involved in destroying insulin-producing pancreatic beta cells to potentially preserve beta cell function SAB Biotherapeutics is pursuing IND filing with U.S. FDA SIOUX FALLS, S.D., Oct. 19, 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 delaying the onset or progression of type 1 diabetes (T1D), today announced that it completed the approval process to commence a first-in-human Phase 1 clinical trial investigating SAB-142 in Australia. The Phase 1 trial will evaluate the company’s lead therapeutic candidate, SAB-142, a first in-class fully-human anti-thymocyte immunoglobulin being developed as a disease-modifying treatment to delay the onset and progression of T1D. This first-in-human trial is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of the SAB-142. Approval by the HREC is confirmation that SAB has successfully completed all pre-clinical safety and efficacy testing required to commence a Phase 1 clinical trial. SAB also intends to submit an Investigational New Drug (IND) application for SAB-142 to the U.S. Food and Drug Administration (FDA) to commence clinical trials in the United States. More information about the Phase 1 clinical trial with SAB-142 (ACTRN:12623001089628) can be found here. “There is tremendous global need for groundbreaking, disease-modifying treatments that can potentially delay the onset of the clinical disease or delay the progression of type 1 diabetes,” said Eddie J. Sullivan, Ph.D., co-founder, President, and Chief Executive Officer of SAB Biotherapeutics. “Today’s announcement brings us one step closer to our plans for expanding global regulatory submissions for SAB-142 to other health authorities in the United States, United Kingdom, and European Union. This clinical milestone is an important first step in our role in addressing an unmet need among patients, and we are proud of the approval to initiate Phase 1 clinical study in Australia for what we belie...