Presentations highlight Phase 1 clinical findings, proof-of-mechanism data, and translational evidence supporting the therapeutic potential of MTX-101 in adults and adolescents with Stage 3 type 1 diabetes

SEATTLE, Oct. 5, 2026 /PRNewswire/ -- Mozart Therapeutics, Inc. ("Mozart"), the leading developer of CD8 Treg network modulators for the treatment of autoimmune disease, today announced the presentation of 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. In three presentations given by Courtney Crane, Ph.D., Mozart's SVP of Translational Medicine and Biology, the company shared clinical and preclinical data supporting the continued development of MTX-101 as a promising investigational therapy for the treatment of type 1 diabetes.

"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 Mozart CEO, Katie Fanning. "Together, these findings continue to support that restoring CD8 regulatory T cell function may offer a differentiated approach to reducing pathogenic immune activity and preserving beta-cell function without broad immune suppression."

Presentation Details

The first presentation, "Phase 1a/b study evaluating the safety, pharmacokinetics, and pharmacodynamics of MTX-101 in healthy adults and type 1 diabetes patients," highlights clinical data collected to date indicating MTX-101 has been relatively safe and well tolerated and may positively affect C-peptide levels in Stage 3 type 1 diabetes.

The second 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," shows preclinical data generated in collaboration with researchers at the University of Colorado. The findings suggest the encouraging clinical and mechanistic findings observed in adults may translate to pediatric patients with Stage 3 type 1 diabetes.

The third 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," summarizes an exploratory analysis of participants with type 1 diabetes in a Phase 1 study. The analysis provides early evidence that MTX-101 selectively modulates novel CD8 regulatory T-cell biology and reduces disease-driving T cells without causing broad immune suppression.

Collectively, the preclinical and clinical data presented support the potential of MTX-101 as a safe, well-tolerated, and selective therapeutic candidate that may restore CD8 regulatory T cell function, reduce pathogenic T cells in adults and adolescents with Stage 3 type 1 diabetes, and promote durable preservation of beta-cell function. The company is in the planning stages of a Phase 2a proof-of-concept study, with enrollment projected to begin in the first half of 2027.

Presentations can be accessed from the Mozart Therapeutics website here: https://www.mozart-tx.com/science/#pubs.

About MTX-101

MTX-101 is an antigen-agnostic bispecific antibody targeting inhibitory KIR and CD8 expressed on regulatory CD8 T cells. This autoimmune checkpoint inhibitor aims to restore the intrinsic functions of CD8 Treg, acting early in the autoimmune disease process to suppress and eliminate pathogenic T cells, halt downstream inflammation, and prevent 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, utilizing a novel approach to restoring immune system homeostasis by targeting the CD8 Treg network. The company global headquarters is in Seattle, WA, with a subsidiary in Brisbane, QLD, that is responsible for the ongoing Phase 1 study in Australia. For more information, visit www.mozart-tx.com and follow the company on LinkedIn @Mozart tx.com.

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SOURCE Mozart Therapeutics