# Use of use of dimethyl fumarate for targeting autoimmunity in type 1 diabetes

> **NIH NIH R21** · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · 2022 · $191,875

## Abstract

Title: Use of use of dimethyl fumarate for targeting autoimmunity in type 1 diabetes
Abstract: Type 1 diabetes (T1D) in an autoimmune disease characterized by T-cell mediated
destruction of insulin producing pancreatic beta-cells. Both innate and adaptive innate immunity
are involved in this process. Immunotherapies so far have failed to achieve long-lasting effects
on islet autoimmunity, so that prevention and reversal of T1D remain an unmet goal. Dimethyl
fumarate (DMF) is an FDA-approved treatment for relapsing remitting multiple sclerosis. Multiple
sclerosis data in both animal models and human subjects have shown that DMF targets innate
and adaptive immune responses through several mechanisms, including the downregulation of
aerobic glycolysis in activated myeloid and lymphoid cells (metabolic inhibition). Our preliminary
data strongly suggests that DMF is a promising drug for the treatment of islet autoimmunity, and
our long-term goal is to launch a clinical trial to test whether DMF preserves insulin secretion in
T1D. As a pre-requisite, a clinical trial would have to be supported by preclinical data that
demonstrate its efficacy in a disease-relevant model. Thus, the goal of this proposal is to conduct
preclinical investigations in the NOD mouse model, a widely accepted model of T1D, to test
whether DMF can antagonize autoimmunity at diabetes onset (diabetes reversal). This approach
is the directly relevant to the clinical setting, where most new therapies being considered for islet
autoimmunity are first tested in clinical trials of patients with recent T1D onset. Therefore, our
specific aims are: 1) To fully test the hypothesis that DMF therapy reverses diabetes and obtain
definitive reproducible efficacy data in NOD mice; 2) To characterize the effects and mechanisms
of action of DMF therapy by studying immune subsets, autoantigen specific responses, pancreas
pathology and β-cell function. This study is significant since DMF has not been tested in T1D and
yet is appears to possess many desirable properties. The proposed project is also innovative
since represents a new approach in treating the disease through a mechanism of action which
includes metabolic inhibition.
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## Key facts

- **NIH application ID:** 10495266
- **Project number:** 5R21AI166368-02
- **Recipient organization:** UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
- **Principal Investigator:** Allison Lorayne Bayer
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $191,875
- **Award type:** 5
- **Project period:** 2021-09-24 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10495266

## Citation

> US National Institutes of Health, RePORTER application 10495266, Use of use of dimethyl fumarate for targeting autoimmunity in type 1 diabetes (5R21AI166368-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10495266. Licensed CC0.

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