SAB-142 for Type 1 Diabetes

(SAFEGUARD Trial)

Recruiting at 60 trial locations

Overseen By Senior Manager Clinical Operations

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: SAb Biotherapeutics, Inc.

Must be taking: Insulin

Must not be taking: Glucocorticoids, Verapamil, Baricitinib, others

Disqualifiers: Autoimmune diseases, Infections, Liver disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

159 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the potential of a new treatment called SAB-142 for individuals with Stage 3 New Onset Type 1 Diabetes (NOT1D), a condition where the body attacks insulin-producing cells. The study aims to evaluate the effectiveness, safety, and tolerability of this treatment. Participants will receive either a placebo or one of two different doses of SAB-142. Those diagnosed with Type 1 Diabetes within the last 100 days may be eligible to join. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but it does exclude those who have used certain diabetes medications or treatments that affect the immune system recently. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that SAB-142 is likely to be safe for humans?

Research has shown that SAB-142 was safe in earlier studies. In a previous study, both healthy volunteers and people with Type 1 diabetes tolerated SAB-142 well.

These trials reported no major side effects (problems caused by the treatment). The evidence also suggests that SAB-142 can be given safely in repeated doses, meaning participants did not experience harmful side effects even with multiple doses.

These findings ease concerns about the safety of SAB-142, making it a promising option for further research. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Type 1 Diabetes?

Most treatments for Type 1 Diabetes involve insulin therapy, which helps manage blood sugar levels but doesn't address the underlying immune response. SAB-142 is unique because it targets the immune system, aiming to preserve the body’s insulin-producing cells. Researchers are excited about this treatment because, unlike standard insulin therapy, SAB-142 could potentially modify the disease course by preventing or slowing the immune attack on the pancreas. This approach could lead to a longer-term solution, reducing the need for frequent insulin injections and improving the quality of life for patients.

What evidence suggests that SAB-142 might be an effective treatment for Type 1 Diabetes?

Research shows that SAB-142 could be a promising treatment for Type 1 Diabetes. Early studies suggest it might slow down or even halt the progression of the disease. In this trial, participants will receive either a high dose or low dose of SAB-142, or a placebo. Previous tests have shown SAB-142 to be safe. It calms the immune system, which is often overactive in people with Type 1 Diabetes, to reduce its harmful effects. Although more research is needed, these early results offer hope for those newly diagnosed with Type 1 Diabetes. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals aged 15-40 diagnosed with Type 1 Diabetes within the last 100 days. They must weigh at least 16 kg and have certain autoantibodies present. Participants need to understand the trial's risks and provide consent. Those misdiagnosed with Type 2 diabetes initially are also eligible if they meet specific criteria.

Inclusion Criteria

My C-peptide level is at least 0.2 nmol/L.

I (or my guardian) have signed and understand the consent form for this study.

I am between 15-40 years old for Part A, or 5-40 years old for Part B.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SAB-142 or placebo in a double-blind, placebo-controlled, parallel-arm study

12 months

Monthly visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SAB-142

Trial Overview

The study tests SAB-142's ability to halt Type 1 Diabetes progression, comparing a high dose, low dose, and placebo in blinded groups. It assesses safety, efficacy, and tolerability in patients newly diagnosed with Stage 3 of the disease.

How Is the Trial Designed?

Group I: Low Dose SAB-142 Experimental Treatment 1 Intervention

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.

Group II: High Dose SAB-142 Experimental Treatment 1 Intervention

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.

Group III: Placebo Placebo Group 1 Intervention

Part B: This is a double-blind, placebo-controlled, parallel-arm study. Enrolment into Part B may commence once all participants in Part A have been randomised.

Who Is Running the Clinical Trial?

SAb Biotherapeutics, Inc.

Lead Sponsor

Trials

7

Recruited

4,200+

Citations

1.

ir.sab.bio

ir.sab.bio/news-releases/news-release-details/sab-bio-present-data-showcasing-progress-development-sab-142

Release Details - Investor Relations | SAB Biotherapeutics

SAB-142 is a potentially disease-modifying, redosable immunotherapy in clinical development for the treatment of autoimmune type 1 diabetes (T1D) ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07187531

Study Details | NCT07187531 | SAFety and Efficacy of ...

This is a Phase 2b, investigator- and participant-blinded, placebo-controlled, parallel-arm study to evaluate the efficacy, safety and tolerability of SAB 142 ...

3.

ir.sab.bio

ir.sab.bio/news-releases/news-release-details/sab-bio-reports-third-quarter-financial-results-and-recent

SAB BIO Reports Third Quarter Financial Results and Recent ...

These data, including a favorable safety profile and a competitive dosing regimen, continue to support the development of SAB-142 as a novel, ...

4.

pharmaceutical-technology.com

pharmaceutical-technology.com/analyst-comment/easd-2025-sab-142-phase-i-data-t1d/

EASD 2025: SAB-142 Phase I data demonstrates novel ...

The data de-risks SAB-142's safety and repeat-dosing profile and broaden its potential across various segments.

5.

news-medical.net

news-medical.net/news/20250206/SAB-BIO-announces-positive-topline-Phase-1-clinical-results-with-potentially-disease-modifying-T1D-therapy-SAB-142.aspx

SAB BIO announces positive topline Phase 1 clinical ...

SAB-142 is now well-positioned to be a transformative therapy in autoimmunity by delaying the progression or onset of type 1 diabetes.

6.

anzctr.org.au

anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12623001089628

Trial Review

The purpose of this study is to test the safety of SAB-142 when given to healthy volunteers or Type 1 diabetes patients. The starting dose will be 0.03 mg ...