SAB Bio announced positive topline data from a Phase 1 trial of SAB-142, a human anti-thymocyte immunoglobulin being developed to delay or prevent type 1 diabetes (T1D). The study in healthy volunteers met its primary safety and pharmacodynamic objectives, paving the way for Phase 2b development. The results confirm that SAB-142 does not cause serum sickness or produce anti-drug antibodies at the target dose.
This news is vital because SAB-142 offers a potential new mechanism of action for managing T1D. Current treatments focus on managing blood sugar levels but don’t address the underlying autoimmune attack. SAB-142’s immunomodulatory action could delay disease onset or slow its progression, representing a significant advance for patients facing a lifetime of intensive disease management. The confirmation of a favorable safety profile further strengthens its potential for chronic use in an outpatient setting, improving patient convenience and adherence.
The Phase 1 trial demonstrated a favorable safety profile of SAB-142 across a dose range of 0.03mg/kg to 2.5mg/kg. Importantly, no serum sickness or anti-drug antibodies were observed. The study also confirmed sustained immunomodulation, with a mechanism of action analogous to rabbit ATG, currently used in T1D. The data supports the drug’s potential for C-peptide preservation, a key marker of pancreatic function.
SAB Bio plans to initiate a Phase 2b trial in 2025, evaluating SAB-142 in both adults and children with new-onset T1D. Positive results from this trial could significantly alter the T1D treatment landscape, offering a new class of therapy to delay or prevent disease progression and potentially improve long-term patient outcomes. The advancement of SAB-142 into later-stage clinical trials represents significant progress toward a much-needed therapeutic approach for T1D.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
