SAB Biotherapeutics, Inc (Nasdaq: SABS), a pioneering clinical-stage biopharmaceutical firm specializing in a revolutionary immunotherapy platform, announced today the successful completion of the approval process for its inaugural Phase 1 clinical trial of SAB-142 in Australia. The trial marks a significant stride towards the development of a fully-human anti-thymocyte immunoglobulin (hIgG) aimed at retarding the onset and progression of type 1 diabetes (T1D). The company’s stock surged in response to this noteworthy announcement.
At the time of this publication, SAB Biotherapeutics, Inc. stock (SABS) has witnessed a surge.
SAB Biotherapeutics Inc
Current Price: $0.76
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The Phase 1 trial will be a critical evaluation of SAB-142, the company’s leading therapeutic candidate, distinguished as a first-in-class fully-human anti-thymocyte immunoglobulin tailored to serve as a disease-modifying intervention to stall the advancement of T1D. The trial’s primary objectives encompass an assessment of the compound’s safety, tolerability, pharmacokinetics, and pharmacodynamics.
The approval granted by the Human Research Ethics Committee (HREC) underscores the successful completion of SAB Biotherapeutics of the requisite pre-clinical safety and efficacy testing, paving the way for the commencement of this pivotal Phase 1 clinical trial. Additionally, SAB has set its sights on submitting an Investigational New Drug (IND) application for SAB-142 to the U.S. Food and Drug Administration (FDA) in order to initiate clinical trials within the United States.
Eddie J. Sullivan, Ph.D., co-founder, President, and Chief Executive Officer of SAB Biotherapeutics, emphasized the urgent global demand for transformative, disease-modifying treatments with the potential to delay the onset or progression of type 1 diabetes. He asserted, “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 believe could be a best-in-class option.”
Alexandra Kropotova, MD, MBA, Executive Vice President and Chief Medical Officer of SAB, highlighted the validated mechanism of action of anti-thymocyte globulin, citing previous clinical trials with rabbit ATG in T1D patients for disease modification. Kropotova expressed anticipation for the Phase 1 trial, underlining SAB-142’s distinction as the first fully-human alternative to rabbit-derived ATG. She articulated confidence in its potential to deliver crucial clinical advantages over its animal-derived counterpart. Kropotova extended gratitude to clinical trial partners and collaborators, acknowledging their shared commitment to advancing innovative therapeutic options for individuals grappling with T1D.