EXCLUSIVE: SAB Biotherapeutics Says Diabetes Immunotherapy Shows Therapeutic Effect In Toxicology Study

SAB Biotherapeutics Inc SABS announced the presentation of safety and pharmacologic data from a GLP toxicology study for SAB-142, a fully human immunotherapeutic being developed for delaying the onset and progression of Type 1 Diabetes.

The data were shared at the Federation of Clinical Immunology Societies in Boston.

The IND-enabling GLP-tox study for SAB-142 was concluded in January this year.

What Happened: In the in vivo study conducted under GLP conditions, SAB-142 was administered at three dose levels of 1, 5, and 10 mg/kg.

Its active control, FDA-approved anti-thymocyte rabbit globulin (ATG), was administered at 5 mg/kg.

The study results showed 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 ATG. 

Why It Matters: Based on the absence of SAB-142-related findings in any safety parameter evaluated in the study, the No Observed-Adverse-Effect-Level was determined to be 10 mg/kg SAB-142, the highest dose level evaluated, thus meeting its primary objective to generate preclinical safety data in support of upcoming IND and CTA filings.

SAB plans to submit an Investigational New Drug (IND) application for SAB-142 to the FDA and initiate a Phase 1 trial in the next few months.

Price Action: SABS shares closed at $0.88 on Tuesday.