SAB-142 Shows Early Preservation of C-Peptide in Adult Type 1 Diabetes Patients
Study Participants on SAB-142 Maintained Insulin Production at Day 120—Divergence From Placebo and Historical Trend Emerges
New data from SAB Biotherapeutics’ (NASDAQ: SABS) Phase 1 HUMAN clinical trial spotlights SAB-142’s initial impact on adults with established autoimmune type 1 diabetes (T1D). The findings, released on March 10, 2026, show that adults treated with this investigational therapy preserved their C-peptide levels—a proxy for the body’s own insulin production—through Day 120, standing in contrast to declines in both the single placebo participant and the historical control from the TN19 study.
Key Data: C-Peptide Levels Preserved for SAB-142 Group
The Phase 1 T1D cohort enrolled six adults (ages 19-40) with longstanding Stage 3 T1D. Four received a 2.5 mg/kg dose of SAB-142, and two were randomized to placebo (one completed the full observation period).
| Cohort | Number of Participants | Treatment | C-Peptide Change at Day 120 |
|---|---|---|---|
| SAB-142 | 4 | 2.5 mg/kg | No decrease; mean increased versus baseline |
| Placebo | 1 (1 completed, 1 dropped) | --- | Decrease observed |
| Historical Control (TN19) | 31 (modeled) | --- | Decline predicted |
This divergence from the expected decline—both in the on-study placebo group and in the modeled TN19 historical cohort—suggests that SAB-142 may be engaging its intended mechanism: stopping immune destruction of insulin-producing beta cells. Notably, biomarker data also suggested T cell exhaustion, a sign the therapy is functioning as designed.
T1D Experts See Encouraging Early Signs Despite Small Sample Size
Dr. Michael J. Haller, a leading voice in pediatric endocrinology at the University of Florida, highlighted the importance of C-peptide preservation as a clinical marker. “While exploratory and early, the initial C-peptide data are encouraging and exactly the type of signal I hope to see at this stage,” said Dr. Haller, noting the results are also backed by supportive biomarker shifts.
Despite the positive direction, the company and independent experts cautioned against drawing statistical conclusions from such a limited cohort. The trends, however, provide a rationale for advancing SAB-142 into the next phase of clinical testing.
Advancement Into Phase 2b ‘SAFEGUARD’ Study to Further Test Efficacy
With Phase 1 objectives achieved—showing safety and initial pharmacodynamics—SAB BIO has moved forward with the Phase 2b ‘SAFEGUARD’ study, which will broaden the patient population to include adults, adolescents, and children with newly diagnosed Stage 3 T1D. This placebo-controlled, multi-site trial aims to deliver pivotal efficacy data, with topline results expected in the second half of 2027.
Potential Shift in T1D Treatment Paradigm Lies Ahead
SAB-142’s method—using a fully human anti-thymocyte globulin to modulate destructive immune cells—draws from the approach of rabbit ATG, which has already demonstrated benefit in new-onset T1D. If further trials validate these early C-peptide preservation results, SAB-142 could help slow disease progression and alter the long-term outlook for many T1D patients.
For those following innovation in diabetes therapy, these new Phase 1 findings put SAB BIO and SAB-142 on the radar. As data matures, observers will be watching closely to see whether the promise of beta cell protection holds in larger, more diverse groups—and what that could mean for the future of T1D care.
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