New Clinical and Preclinical Findings Support Continued Development of MTX-101 for Type 1 Diabetes
Mozart Therapeutics, Inc. (“Mozart”), a developer of CD8 Treg network modulators for autoimmune diseases, announced the presentation of new clinical and preclinical data for its lead development program, MTX-101, at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD), held September 28–October 2, 2026, in Milan, Italy.
Across three presentations, Courtney Crane, Ph.D., Mozart’s SVP of Translational Medicine and Biology, presented findings supporting the continued development of MTX-101 as an investigational therapy for type 1 diabetes.
Key Highlights
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Clinical data from the Phase 1a/b study indicate that MTX-101 was relatively safe and well tolerated in the participants evaluated to date.
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Early findings suggest MTX-101 may have a positive effect on C-peptide levels in patients with Stage 3 type 1 diabetes.
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Preclinical research suggests that findings observed in adults may potentially translate to pediatric patients with Stage 3 type 1 diabetes.
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Exploratory clinical analyses provide early evidence that MTX-101 may selectively modulate CD8 regulatory T-cell biology.
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Findings suggest MTX-101 may reduce disease-driving T cells without broad immune suppression.
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Mozart is planning a Phase 2a proof-of-concept study, with enrollment projected to begin in the first half of 2027.
Three Presentations at EASD 2026
1. Phase 1a/b Clinical Study of MTX-101
Presentation: “Phase 1a/b study evaluating the safety, pharmacokinetics, and pharmacodynamics of MTX-101 in healthy adults and type 1 diabetes patients”
The presentation highlighted clinical data collected to date from the Phase 1a/b study.
Key findings included:
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MTX-101 was relatively safe and well tolerated in the participants evaluated.
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Early data indicated a potential positive effect on C-peptide levels in individuals with Stage 3 type 1 diabetes.
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The findings provide early clinical support for continued evaluation of MTX-101.
2. Evaluation of CD8 Treg Activity in Type 1 Diabetes
Presentation: “Evaluation of CD8 Treg prevalence and MTX-101-mediated activation of peripheral blood mononuclear cells from newly diagnosed pediatric and adult type 1 diabetes patients”
This preclinical study was conducted in collaboration with researchers at the University of Colorado.
The findings suggest that:
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CD8 regulatory T-cell biology may be relevant across adult and pediatric type 1 diabetes populations.
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The encouraging clinical and mechanistic findings observed in adults may potentially translate to pediatric patients with Stage 3 type 1 diabetes.
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The data provide additional support for investigating MTX-101 across different patient populations.
3. Mechanism of Action of MTX-101
Presentation: “Evaluation of the mechanism of action of MTX-101, a novel regulatory T-cell modulator, in a Phase 1b clinical study in adults with Stage 3 type 1 diabetes”
This exploratory analysis evaluated participants with type 1 diabetes who were enrolled in the Phase 1 study.
The analysis provided early evidence that MTX-101:
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Selectively modulates CD8 regulatory T-cell biology.
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May reduce disease-driving T cells.
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May achieve these effects without broad immune suppression.
What the Findings Could Mean for Type 1 Diabetes
Collectively, the clinical and preclinical findings presented at EASD 2026 support the continued investigation of MTX-101 as a potential disease-modifying therapy for type 1 diabetes.
According to Mozart Therapeutics, the data suggest that MTX-101 may:
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Restore CD8 regulatory T-cell function.
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Reduce pathogenic T-cell activity.
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Support preservation of beta-cell function.
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Target autoimmune activity more selectively rather than broadly suppressing the immune system.
“The data presented at EASD demonstrate the breadth of evidence supporting MTX-101, from early clinical safety and biomarker findings to its selective mechanism of action and potential relevance in patients with Stage 3 type 1 diabetes,” said Katie Fanning, CEO of Mozart Therapeutics.
Next Step: Phase 2a Study
Mozart Therapeutics is currently in the planning stages of a Phase 2a proof-of-concept study of MTX-101.
Enrollment is projected to begin in the first half of 2027.
About MTX-101
MTX-101 is an antigen-agnostic bispecific antibody designed to target inhibitory KIR and CD8 expressed on regulatory CD8 T cells.
The investigational therapy is intended to act as an autoimmune checkpoint inhibitor, with the goal of restoring the intrinsic functions of CD8 regulatory T cells.
According to Mozart Therapeutics, this approach is designed to act early in the autoimmune disease process by:
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Suppressing and eliminating pathogenic T cells.
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Reducing downstream inflammation.
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Potentially preventing tissue destruction.
About Mozart Therapeutics
Mozart Therapeutics and Mozart Therapeutics Australia Pty Ltd are focused on developing first-in-class disease-modifying therapies for autoimmune and inflammatory diseases.
The company’s approach centers on restoring immune system homeostasis by targeting the CD8 Treg network.
Mozart Therapeutics is headquartered in Seattle, Washington, with an Australian subsidiary in Brisbane, Queensland, responsible for the ongoing Phase 1 study in Australia.
Learn More
The presentations are available through the Mozart Therapeutics website:
Mozart Therapeutics Science & Publications:
https://www.mozart-tx.com/science/#pubs
Company Website:
https://www.mozart-tx.com
