0001193125-26-168569
SEC filingSAB Biotherapeutics presented Phase 1 trial data for SAB-142 showing C-peptide preservation in all 4 T1D participants and improved glycemic control, presented at IDS 2026 Congress.
SAB Biotherapeutics disclosed positive Phase 1 data for SAB-142, its fully human anti-thymocyte globulin (hATG) for type 1 diabetes (T1D), at the 21st Immunology of Diabetes Society Congress. In the T1D cohort of 6 adults with established disease (Stage 3, diagnosis 28-40 months prior, residual C-peptide >0.2 nmol/L), all 4 receiving 2.5 mg/kg SAB-142 preserved C-peptide levels through Day 120 post-administration, versus decline in the completer placebo participant. Notably, 3 of 4 showed super responder profiles with mean C-peptide above baseline, mirroring rabbit ATG (rATG) study outcomes where super responders maintained levels at Month 24. This preservation correlated with increased TIGIT+ CD4+ Tconv cell exhaustion, confirming SAB-142's mechanism of inducing immunomodulation without depletion. Glycemic control improved significantly, with continuous glucose monitoring showing mean Time in Range rising from 73% to 85%, independent of exogenous insulin changes. Chief Medical Officer Alexandra Kropotova highlighted sustained immunomodulation supporting SAB-142's potential as a safe, redosable long-term therapy across T1D stages. CEO Samuel J. Reich emphasized building confidence in its disease-modifying profile ahead of Phase 2b SAFEGUARD topline results in 2H 2027. SAFEGUARD is a multi-center, placebo-controlled trial in new-onset Stage 3 T1D patients, with Part A dose-ranging and Part B confirmatory, featuring two infusions six months apart and a long-term extension. The data reinforces SAB-142's analogy to rATG, which slowed progression in prior trials, positioning it as a potential best-in-class immunotherapy to preserve beta cells.