FDA Clears IND Application for Type 1 Diabetes Therapy SAB-142 by SAB Biotherapeutics

SAB Biotherapeutics has announced that its investigational new drug (IND) application for its phase 1 clinical trial of SAB-142, a therapy for type 1 diabetes (T1D), has received clearance from the U.S. Food and Drug Administration (FDA). This approval allows SAB Biotherapeutics to enroll patients with type 1 diabetes in the United States into the ongoing HUMAN trial. The trial is designed to generate data for an upcoming Phase 2B trial.

The HUMAN trial, which stands for "fully HUman anti-thymocyte biologic in first-in-MAN clinical study," is a phase 1, randomized, double-blind, placebo-controlled, single-ascending dose, adaptive design clinical study. It aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous SAB-142 in both healthy volunteers and participants with T1D.

Samuel J. Reich, Chairman and CEO of SAB, expressed excitement over the FDA's clearance, highlighting the company's commitment to slowing disease progression in patients with new or recent onset stage 3 type 1 diabetes. Reich emphasized the potential of SAB-142 to significantly improve the lives of those affected by the disease through their innovative therapy.

The phase 1 study of SAB-142 is a first-in-man trial aimed at establishing the safety, tolerability, pharmacokinetic (PK), immunogenicity, and pharmacodynamic (PD) profile of this human anti-thymocyte biologic. The study follows a randomized, double-blind, single-ascending dose trial design, with doses ranging from .03mg/kg to 2.5mg/kg. This dose range is similar to that studied in the MELD-ATG study, a dose-ranging rabbit ATG study in new onset T1D patients that will announce its topline results in 2025. The anticipated outcomes include validating the differentiated safety, immunogenicity, and tolerability profiles of SAB-142, with expectations of 0% serum sickness and no anti-drug antibodies (nAbs). The study also aims to validate the mechanism of action of SAB-142 in humans and establish proof of biological activity. A Phase 1 update provided by SAB on April 16, 2024, noted that the third cohort had been fully enrolled and dosed, with no observed serum sickness.

SAB-142 is a human alternative to rabbit anti-thymocyte globulin (ATG). Its mechanism of action is similar to rabbit ATG, which has shown clinical validation in several trials for T1D, demonstrating the ability to slow disease progression in patients with new or recent onset of Stage 3 type 1 diabetes. Studies have demonstrated that a single, low dose of rabbit ATG can modulate the immune response, helping to slow beta cell destruction and preserve these cells' insulin-generating capability, which is crucial for regulating blood sugar levels.

SAB-142 targets multiple immune cells that are involved in the destruction of pancreatic beta cells. By preventing the immune system from attacking these cells, the therapy has the potential to preserve insulin-producing beta cells. Unlike rabbit ATG, which can induce serum sickness and anti-drug antibodies in humans, SAB-142 is a human biologic treatment, intended to allow safe and consistent re-dosing for type 1 diabetes, a lifelong chronic disease, without the major adverse immune reactions associated with animal-derived ATG.

SAB Biotherapeutics is a clinical-stage biopharmaceutical company focused on developing human, multi-targeted, high-potency immunoglobulins (IgGs). These treatments are developed without the need for human donors or convalescent plasma and are aimed at treating and preventing immune and autoimmune disorders. The company’s lead asset, SAB-142, targets T1D with a disease-modifying therapeutic approach designed to delay onset and potentially prevent disease progression. Using advanced genetic engineering and antibody science, SAB has developed Transchromosomic (Tc) Bovine™, the only transgenic animal with a human artificial chromosome. Through its DiversitAb™ drug development production system, SAB can generate a diverse range of targeted, high-potency human IgGs addressing various unmet medical needs without relying on convalescent plasma or human donors.