Mozart Therapeutics Announces Podium Presentation at Immunology of Diabetes Congress; Shows Potential for Lead Program, MTX-101, to Restore Insulin Production in Type 1 Diabetes

Preclinical data in type 1 diabetes organoid model demonstrate MTX-101 can reestablish functionality of pancreatic beta cells

Phase 1 clinical study underway to evaluate MTX-101 in healthy adults and patients with celiac disease and T1D

SEATTLE, Nov. 5, 2024 /PRNewswire/ -- Mozart Therapeutics, a clinical-stage biopharmaceutical company focused on the development of regulatory CD8 T cell (Treg) modulators in autoimmune diseases, announces today new preclinical data on its lead program, MTX-101, in type 1 diabetes (T1D). The data were revealed during an oral presentation, "Pre-clinical characterization of MTX-101, a novel bispecific regulatory CD8 T cell modulator designed for the treatment of type 1 diabetes patients," at the 2024 Immunology of Diabetes Society 20^th Congress, November 4–8, in Bruges, Belgium.

Courtney Crane, Ph.D., Senior Vice President of Biology and Translational Medicine at Mozart Therapeutics, presented data demonstrating that MTX-101 selectively restores the inherent function of CD8 Treg to eradicate pathogenic CD4 T cells, which are implicated in the destruction of insulin-producing pancreatic islet beta cells and corresponding drivers of disease pathogenesis in T1D. Dr. Crane presented additional data derived from T1D organoid tissue showing that MTX-101 reduces islet beta cell death and restores beta cell function, including insulin production, in this model.  

"We are pleased to highlight this new preclinical data on MTX-101 in type 1 diabetes," said Dr. Crane. "Our research builds on the literature that established the correlation between CD8 Treg dysfunction and type 1 diabetes, and demonstrates the ability of MTX-101 to restore CD8 Treg function and the potential for durable immune homeostasis in autoimmune disease. We look forward to evaluating this candidate in patients with type 1 diabetes during Part B of our ongoing Phase 1 study." Dr. Crane's podium presentation came in advance of the Company's poster presentation supporting the use of translational platforms to advance preclinical evaluation of MTX-101 in immune cells and tissues derived from patients with T1D.

A Ph1 study with MTX-101 in healthy adults and patients with T1D and celiac disease is ongoing.  "For both these diseases, which impact millions of patients, there are very limited therapeutic options," said Jason Chien, M.D. M.S., Chief Medical Officer at Mozart Therapeutics. In 2021, T1D affected 8.42 million people worldwide, with approximately 510,000 new cases per year. "Although there has been some recent progress in immunotherapy-based treatments, there remains a very significant unmet need for type 1 diabetes patients who are still waiting for an effective treatment that can durably prevent the progression of their disease."

Poster Presentation Details:

Poster Session 2:  November 7, 2024, at 5:30–7:00 pm Central European Standard Time
Poster Title:  Characterization of a reversibly dysfunctional regulatory CD8 T cell population responsible for pathogenic T cell elimination in T1D patients

The poster can be accessed from the Mozart Therapeutics website.

About MTX-101

MTX-101 is a bispecific antibody targeting inhibitory KIR and CD8 expressed on regulatory CD8 T cells. This autoimmune checkpoint inhibitor aims to restore the intrinsic functions of regulatory CD8 T cells, acting early in the autoimmune disease process to suppress and eliminate pathogenic cells, halt downstream inflammation, and prevent tissue destruction. MTX-101 is currently being evaluated in a randomized, blinded, placebo-controlled Phase 1 trial (NCT06324604) in healthy adults (study Part A) and in patients with type 1 diabetes or celiac disease (study Part B). The clinical study is evaluating the safety, pharmacokinetics, and pharmacodynamics of MTX-101; in Part B, disease-specific biomarkers will also be assessed.

About Mozart Therapeutics

Mozart Therapeutics is focused on developing first-in-class disease-modifying therapies for autoimmune diseases, utilizing a novel approach to restoring immune system function by targeting the CD8 T regulatory network. The company is headquartered in Seattle, WA. For more information, visit www.mozart-tx.com and follow the company on LinkedIn @Mozart–tx.com

SOURCE Mozart Therapeutics