NCT07670650 SAB-142 Diabetes Mellitus, Type 1 Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready landscape. This focused report examines NCT07670650—PRISE (Personalized Response and Immunologic Surveillance of Endogenous C-Peptide Preservation in New, Recent, and Established Onset Type 1 Diabetes Treated With Human Anti-Thymocyte Globulin [h-ATG]) Study (PRISE-hATG)—using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, Drug & Asset MCP for mechanism and development context, and Company & Deal Intelligence MCP for sponsor background. Explore PatSnap MCP Servers to reproduce the workflow inside an AI research process.
MCP evidence snapshot: 20 July 2026; publication date: 20 July 2026. Trial records can change after the snapshot and should be rechecked before operational decisions.
Why NCT07670650 is a hot trial to watch
Diabetes Mellitus, Type 1 is increasingly segmented by mechanism, biomarker, treatment setting, geography and endpoint architecture. NCT07670650 is notable because it evaluates SAB-142 in a Phase 3 design while This is a measure of endogenous insulin production and β cell function (change from baseline in C-peptide ln \[AUC+1\]. serves as the main decision variable. The critical question is whether the protocol can convert its rationale into a clinically interpretable and operationally credible readout.
PatSnap Clinical Trials MCP makes protocol fields machine-readable, while the companion asset and organization servers add development-status, target and sponsor context.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07670650 |
| Official title | PRISE (Personalized Response and Immunologic Surveillance of Endogenous C-Peptide Preservation in New, Recent, and Established Onset Type 1 Diabetes Treated With Human Anti-Thymocyte Globulin [h-ATG]) Study (PRISE-hATG) |
| Phase / status | Phase 3 / Not yet recruiting |
| Intervention | SAB-142, Placebo |
| Sponsor | University of Florida |
| Collaborators | SAB Biotherapeutics, Inc. |
| Geography | United States |
| Enrollment | 108 |
| Primary endpoint | This is a measure of endogenous insulin production and β cell function (change from baseline in C-peptide ln \[AUC+1\]. |
| Endpoint time frame | Dose administration to 12 Months |
| Primary completion / readout proxy | [object Object] |
Design and endpoint interpretation
The phase label is only the starting point. Allocation is Randomized, masking is Triple, and the intervention model is Parallel Assignment. Planned enrollment of 108 participants across United States shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Primary: This is a measure of endogenous insulin production and β cell function (change from baseline in C-peptide ln \[AUC+1\]. (Dose administration to 12 Months)
- Secondary: This is achange from baseline in C--peptide ln \[AUC+1\] at 12 months) in a priori in vitro identified "responders" and "non-responders" to SAB-142 and compared to placebo. (Baseline, Months 3, 6, 9 and 12)
- Secondary: Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs). (Dose administration to 12 Months)
- Secondary: Evaluate SAB-142 serum concentrations over the infusion (Days 1 and 2 of each treatment period (pre- and post-dose/end of infusion [EOI]), plus Week 1 for TP1 (for participants that attend the optional in-clinic visit), Week 4, and Months 3, and 7.)
- Secondary: Incidence and titres of anti-SAB-142 antibodies in serum including neutralising antibodies (nAbs) if indicated. (Baseline, Week 1 (for participants that attend the optional in-clinic visit), Week 4, Months 3, 6, 7, 9, and 12.)
Benchmark readouts in the surrounding field
- 1394-P: Impact of Finerenone on Albuminuria in Type 1 Diabetes by Baseline HbA1c Levels and Diabetes Duration: An Exploratory Analysis of the FINE-ONE Trial (Phase 2): UACR(6-month): P-Value = 0.0001; UACR(6-month): P-Value = 0.0001
- A Phase 3 Single Center Study of Islet Transplantation in Non-uremic Diabetic Patients (Phase 3): Safety and Feasibility of Islet Transplantation to Treat Type-1 Diabetes (T1D) = 2 participants
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of RDX-002 on Postprandial Triglycerides in Patients Discontinuing the Glucagon-like Peptide-1 (GLP-1) Agonists, Semaglutide, or Tirzepatide for the Treatment of Obesity (Phase 2): Incremental Postprandial Triglycerides (TG)(Mean) = 43.81 percent change (Standard Deviation, 92.373); Incremental Postprandial Triglycerides (TG)(Mean) = -51.91 percent change (Standard Deviation, 72.293)
These indexed results are contextual benchmarks, not direct head-to-head evidence. Population, treatment line, endpoint definitions, follow-up and analysis sets may differ. Their value is to clarify the type and magnitude of evidence already visible in the competitive landscape.
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Asset and sponsor context
Drug & Asset context: SAB-142 (Phase 3; target not reported)
Company & Deal Intelligence context: University of Florida — United States — https://www.ufl.edu
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can decide whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Sequencing evidence: comparative data after the most relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter probability of success before a headline data release.
Bottom line
NCT07670650 is a focused lens on Diabetes Mellitus, Type 1 development. Its value will be determined by whether SAB-142 can convert the current design into evidence that is clinically meaningful, operationally credible and differentiated from indexed benchmark readouts.
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