SAB Biotherapeutics Gets FDA Clearance To Advance Phase 1 Trial Of SAB-142 In Type-1 Diabetes

(RTTNews) - SAB Biotherapeutics, Inc. (SABS) announced on Tuesday that the FDA has granted clearance for an investigational new drug application to advance its phase 1 clinical trial of SAB-142 for treating type-1 diabetes.

Phase 1 trial of SAB-142 involves a human trial, to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamic profile of the human anti-thymocyte biologic SAB-142 in healthy volunteers and patients with type-1 diabetes.

The study follows a randomized, double-blind, single-ascending dose trial design, with dosages ranging from .03mg/kg to 2.5mg/kg, a range similar to that explored in the MELD-ATG study, a dose-ranging rabbit ATG study in individuals with new-onset T1D.

The company stated that similar to rabbit ATG, SAB-142 specifically targets various immune cells responsible for destroying pancreatic beta cells, but without the potential risk of triggering significant adverse immune reactions associated with animal ATG administration.