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Also known as High Dose SAB-142
SAB-142 · 2 trials · 2 indications
This is a measure of endogenous insulin production and β cell function (change from baseline in C-peptide ln \[AUC+1\].
This is a measure of endogenous insulin production and β cell function (change from baseline in C-peptide ln \[AUC+1\] at 12 months)
This is a measure of endogenous insulin production and β-cell function (change from baseline in C-peptide ln \[AUC+1\] at 24 months versus control).
| Arm | Type | Description |
|---|---|---|
| SAB-142 | EXPERIMENTAL | SAB-142 in recent and established onset T1D |
| Placebo | PLACEBO_COMPARATOR | Placebo Comparator |
| High Dose SAB-142 | EXPERIMENTAL | Part A: Open-label, parallel arm study. Part B: Double-blind, placebo-controlled, parallel-arm study. Enrolment into Part B may commence once all participants in Part A have been randomised. Part C: Long-term efficacy and safety study. Participants continue treatment according to assigned induction dose. Eligible participants who received placebo in Part B and enter Part C will be randomised to active SAB-142 treatment. |
| Low Dose SAB-142 | EXPERIMENTAL | Part A: Open-label, parallel arm study. Part B: Double-blind, placebo-controlled, parallel-arm study. Enrolment into Part B may commence once all participants in Part A have been randomised. Part C: Long-term efficacy and safety study. Participants continue treatment according to assigned induction dose. Eligible participants who received placebo in Part B and enter Part C will be randomised to active SAB-142 treatment. |
| Name | Type | Description |
|---|---|---|
| SAB-142 | DRUG | Treatment Period 1 (Induction) Day 1: SAB-142 0.5 mg/kg IV Day 2: SAB-142 2.0 mg/kg IV Treatment Period 2 (Month 6 Maintenance) Day 1: SAB-142 0.5 mg/kg IV Day 2: SAB-142 1.0 mg/kg IV Total induction dose: 2.5 mg/kg Total maintenance dose: 1.5 mg/kg |
| Placebo | DRUG | Placebo Comparator: Placebo |
| High Dose SAB-142 | DRUG | High Dose SAB-142 |
| Low Dose SAB-142 | DRUG | Low Dose SAB-142 |
Inclusion Criteria: 1. Participant and/or appropriate legal guardian for participants below the legal age of consent must have given written informed consent and/or assent according to local, regional and/or country specific guidance before any study-related activities are carried out and must be a...
Top 10 of 16 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 6 | PHASE3 | Tirzepatide, Baricitinib, LY4057996, Insulin Lispro, LY3938577 |
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 5 | PHASE3 | Insulin icodec, Insulin aspart, NNC0194-0499, Semaglutide, NNC0497-0040 |
| Sanofi SA Sponsored ADR | SNY | 12 | PHASE3 | teplizumab/mL, Brivekimig, Frexalimab, Insulin |
| Vertex Pharmaceuticals Incorporated | VRTX | 3 | PHASE3 | VX-880, VX-017, VX-264 |
| vTv Therapeutics, Inc. Class A | VTVT | 1 | PHASE3 | Cadisegliatin |
| SAB Biotherapeutics, Inc. | SABS | 1 | PHASE2 | SAB-142 |
| MannKind Corporation | MNKD | 2 | PHASE2 | Technosphere Insulin |
| Creative Medical Technology Holdings, Inc. | CELZ | 1 | PHASE1 | CELZ-201 |
| Immunocore Holdings Plc Shs Sponsored American Depositary Shares Repr 1 Sh | IMCR | 1 | PHASE1 | IMC-S118AI |
| Sana Biotechnology, Inc. | SANA | 1 | EARLY_PHASE1 | UP421 |
SAB-142 is being developed for the treatment of Type 1 Diabetes. It is designed to interfere with the autoimmune process that destroys insulin-producing cells, with the goal of preserving endogenous C-peptide production in people with new, recent, or established onset Type 1 Diabetes.
SAB-142 targets thymocytes, cells of the immune system that are central to T cell development and the autoimmune attack on pancreatic beta cells in Type 1 Diabetes. By acting on thymocytes, the drug is intended to blunt the immune-mediated destruction of insulin-producing cells.
SAB-142 is being developed by SAB Biotherapeutics, Inc., which trades on the Nasdaq under the ticker SABS. The company is running the clinical program for the asset in Type 1 Diabetes across multiple countries.
SAB-142 is in Phase 3 development for Type 1 Diabetes. It is an investigational therapy and is not approved for commercial use. The program includes a Phase 3 study and a Phase 2 study, both of which are active, with a combined planned enrollment of 267 participants.
SAB-142 is being studied in two trials. NCT07670650, the PRISE study, is a Phase 3 trial in Type 1 Diabetes in the United States that is not yet recruiting, with planned enrollment of 108. NCT07187531 is a Phase 2 safety and efficacy trial that is recruiting across the United States, Europe, Australia, and New Zealand, with planned enrollment of 159.
Yes. High Dose SAB-142 is another name used for SAB-142, so searches for either term refer to the same investigational asset being developed by SAB Biotherapeutics for Type 1 Diabetes. Both names describe the same clinical program, which includes the Phase 3 PRISE study and a Phase 2 trial.