SEATTLE – October 05, 2026 -- Mozart Therapeutics presented three new data sets on its lead candidate 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, advancing the bispecific antibody toward a planned Phase 2a trial in Stage 3 type 1 diabetes with enrollment targeted for the first half of 2027.
Phase 1a/b data show MTX-101 is well tolerated and may affect C-peptide levels
The first presentation detailed safety, pharmacokinetic and pharmacodynamic results from a Phase 1a/b study in healthy adults and type 1 diabetes patients. Clinical data collected to date indicate MTX-101 has been relatively safe and well tolerated, with early signals suggesting a positive effect on C-peptide levels in patients with Stage 3 disease.
University of Colorado collaboration points to pediatric relevance
A second presentation, developed with researchers at the University of Colorado, evaluated CD8 Treg prevalence and MTX-101-mediated activation of peripheral blood mononuclear cells from newly diagnosed pediatric and adult type 1 diabetes patients. The findings indicate that clinical and mechanistic effects observed in adults may extend to pediatric patients with Stage 3 disease.
Mechanism-of-action analysis shows selective T-cell modulation without broad immune suppression
The third presentation summarized an exploratory analysis from a Phase 1b study in adults with Stage 3 type 1 diabetes, providing early evidence that MTX-101 selectively modulates CD8 regulatory T-cell biology and reduces disease-driving T cells without triggering broad immune suppression. All three presentations were delivered by Courtney Crane, Ph.D., Mozart's SVP of Translational Medicine and Biology.
Mozart targets differentiated mechanism to preserve beta-cell function
MTX-101 is an antigen-agnostic bispecific antibody targeting inhibitory KIR and CD8 on regulatory CD8 T cells, designed to act as an autoimmune checkpoint inhibitor that suppresses pathogenic T cells early in disease progression. Mozart CEO Katie Fanning said the data presented at EASD span early clinical safety and biomarker findings to the therapy's selective mechanism of action, supporting the premise that restoring CD8 regulatory T cell function could reduce pathogenic immune activity and preserve beta-cell function without broad immune suppression.
Mozart is now in the planning stages of a Phase 2a proof-of-concept study in adults and adolescents with Stage 3 type 1 diabetes.