What prior FDA approvals exist?

The FDA has approved several treatments for Type 1 Diabetes, primarily focusing on insulin therapy to manage blood glucose levels. However, in terms of immunomodulatory agents aimed at preserving endogenous insulin secretion, there are limited approvals. One notable example is teplizumab, an anti-CD3 monoclonal antibody, which has shown promise in delaying the onset of T1D in at-risk individuals by modulating the immune response. Other treatments in this category are still largely in experimental stages or clinical trials, similar to Frexalimab.

What other types of research exist?

Promising novel alternatives to Frexalimab for T1D patients include: 1) Teplizumab, an anti-CD3 monoclonal antibody that has shown potential in delaying the onset of T1D in high-risk individuals. 2) Treg-based therapies, which involve expanding regulatory T cells to modulate the immune response and preserve beta-cell function. 3) Sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, which, while primarily used for T2D, is being explored for its benefits in T1D management. These alternatives are in various stages of clinical development and may offer new avenues for preserving endogenous insulin secretion in T1D patients.

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Monoclonal Antibodies

Frexalimab + Insulin for Type 1 Diabetes (FABULINUS Trial)

Q: What side effects are associated with this type of intervention?

Common treatments for Type 1 Diabetes include insulin therapy and immunomodulatory agents. Insulin therapy, essential for managing blood glucose levels, can cause side effects such as hypoglycemia, weight gain, and injection site reactions. Immunomodulatory agents, like those being studied in the Frexalimab trial, aim to preserve endogenous insulin secretion and may have side effects including increased risk of infections, allergic reactions, and potential impacts on immune function. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate risks effectively.

Phase 2

Recruiting

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be positive for at least 1 of the following T1D autoantibodies confirmed by medical history and/or obtained at study screening: Glutamic acid decarboxylase (GAD-65), Insulinoma Antigen-2 (IA-2), Zinc-transporter 8 (ZnT8) or Insulin (if obtained not later than 10 days after exogenous insulin therapy initiation)

Receiving at least one of the following T1D standard of care (SOC), insulin hormone replacement therapy: one or multiple daily injections (MDI) of basal insulin, prandial insulin and/or premixed insulin, or continuous subcutaneous insulin infusion (CSII)

Must not have

Serious systemic viral, bacterial or fungal infection (eg, pneumonia, pyelonephritis), infection requiring hospitalization or IV antibiotics or significant chronic viral (including history of recurrent or active herpes zoster, acute or active cytomegalovirus (CMV), Epstein-Barr Virus (EBV) as determined at screening), bacterial, or fungal infection (eg, osteomyelitis) 30 days before and during screening

Participants with a history of invasive opportunistic infections, such as, but not limited to histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, and aspergillosis, regardless of resolution

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 52 and week 104

Summary

This trial is testing a new drug called frexalimab in young people with newly diagnosed Type 1 Diabetes. The goal is to see if it can help their bodies keep making insulin. The study will compare different doses of the drug to find the safest and most effective amount.

Who is the study for?

The FABULINUS trial is for young individuals with newly diagnosed Type 1 Diabetes. Participants must be between 12-21 years old, vaccinated according to local schedules, and have started insulin therapy within the last 90 days. They should test positive for certain diabetes-related autoantibodies and agree to use contraception.

What is being tested?

This study tests Frexalimab's safety and effectiveness in preserving natural insulin production compared to a placebo in youths on standard insulin treatment. It's a double-blind Phase 2 trial with two parts: initial dose safety assessment followed by dose-finding over up to 104 weeks of treatment.

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions due to Frexalimab or the placebo on top of their regular insulin therapy throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have at least one type 1 diabetes autoantibody (GAD-65, IA-2, ZnT8, or Insulin).

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I am on insulin therapy for Type 1 Diabetes.

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I have been diagnosed with Type 1 Diabetes according to the American Diabetes Association.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had serious infections or been hospitalized for infections in the last 30 days.

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I have had serious infections like histoplasmosis or candidiasis.

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I have a history or risk of blood clots or heart-related issues.

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I have not taken any immunosuppressive drugs in the last 12 weeks.

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I have had cancer in any part of my body within the last 5 years.

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I have a history of or currently have low levels of antibodies.

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I have received treatments like Thymoglobulin® or teplizumab.

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I haven't had any live vaccines in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 52 and week 104

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 52 and week 104

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 52 and week 104 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline to W52 in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration

Secondary study objectives

Proportion of participants who remain C-peptide positive (mean 2h MMTT stimulated C-peptide concentration ≥0.2 nmol/L) at W52 and W104

Proportion of participants with reduction from baseline to W52 and W104 of less than 10% in mean 2h MMTT stimulated C-peptide concentration

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Frexalimab Dose 3Experimental Treatment2 Interventions

Group II: Frexalimab Dose 2Experimental Treatment2 Interventions

Group III: Frexalimab Dose 1Experimental Treatment2 Interventions

Group IV: PlaceboPlacebo Group2 Interventions

Matching Placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Insulin

2000

Completed Phase 4

~4280

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Type 1 Diabetes (T1D) include insulin therapy and immunomodulatory agents. Insulin therapy is essential as it replaces the insulin that the body can no longer produce, helping to maintain normal blood glucose levels and prevent complications. Immunomodulatory agents, such as those being studied in the Frexalimab trial, aim to preserve the function of the remaining beta-cells by modulating the immune response. This approach is significant for T1D patients as it could reduce the need for exogenous insulin and improve long-term outcomes by preserving endogenous insulin secretion.

Functional loss of pancreatic islets in type 2 diabetes: How can we halt it?Exenatide Alters Gene Expression of Neural Cell Adhesion Molecule (NCAM), Intercellular Cell Adhesion Molecule (ICAM), and Vascular Cell Adhesion Molecule (VCAM) in the Hippocampus of Type 2 Diabetic Model Mice.Effects of exenatide alone and in combination with daclizumab on beta-cell function in long-standing type 1 diabetes.