Mozart Therapeutics Inc, a developer of CD8 Treg network modulators for the treatment of autoimmune disease, announced on Monday the presentation of clinical and preclinical data for its lead development programme, MTX-101, at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD), held last week 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 company says that 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. Mozart Therapeutics is in the planning stages of a Phase 2a proof-of-concept study, with enrolment projected to begin in the first half of 2027.

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.