SAB Biotherapeutics Inc SABS announced that the first HUMAN trial participants (Fully HUman anti-thymocyte biologic in a 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 type-1 diabetes (T1D).
SAB-142 is a first-in-class, fully human anti-thymocyte immunoglobulin developed as a disease-modifying treatment to delay the onset and progression of T1D.
SAB-142 directly and specifically targets multiple immune cells involved in destroying insulin-producing pancreatic beta cells to potentially preserve beta cell function.
The trial's primary objective is two-fold:
- To generate data on differentiated safety and immunogenicity
- To establish a Proof of Biological Activity (POBA) for SAB-142.
SAB is on track to file an Investigational New Drug (IND) application for SAB-142 with the FDA in 2024, along with filings in the U.K. and EU countries to enable efficient progress towards the Phase 2b development.
In October, SAB Biotherapeutics exclusively told Benzinga that it raised $130 million via equity private placement to fund the clinical advancement of SAB-142.
In June, SAB Biotherapeutics presented safety and pharmacologic data from a GLP toxicology study for SAB-142, showing that SAB-142 and the rabbit ATG modulate key T-cell subsets relevant for T1D similarly, thus confirming that SAB-142's mechanism of action is similar to rabbit globulin.
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