Phase Ib of the trial will assess the safety, PK, PD and disease-specific biomarkers of MTX-101 in patients with type 1 diabetes mellitus or coeliac disease. Credit: YURIMA/Shutterstock.

US-based biopharmaceutical company Mozart Therapeutics has dosed the first subjects in its Phase Ia/b trial of MTX-101, a CD8 Treg modulator and autoimmune checkpoint inhibitor being developed for the potential treatment of autoimmune diseases.

The study’s Phase Ia segment is a single and multiple ascending dose escalation trial that aims to assess MTX-101’s pharmacokinetics (PK), safety and pharmacodynamics (PD) in healthy adults.

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The subsequent Phase Ib portion will assess the drug’s safety, PK, PD and disease-specific biomarkers in patients diagnosed with type 1 diabetes mellitus or coeliac disease.

Mozart Therapeutics president and CEO Katie Fanning said: “Dosing the first cohort of participants in this Phase Ia/b clinical study with MTX-101 is a significant milestone for Mozart, marking our transition into the clinic and bringing us closer to reaching our goal of changing the treatment paradigm by modifying the course of autoimmune disease in every patient.

“In autoimmune disease, CD8 Treg fail to recognise and eliminate pathogenic or self-reactive CD4 T cells, resulting in downstream proinflammatory events and perpetuation of tissue destruction.

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“The aim of MTX-101 is to selectively target a fundamental cause of immune dysregulation and restore immune homeostasis in autoimmune disease.”

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MTX-101 is a bispecific antibody designed to reinstate the natural functionality of regulatory CD8 T cells by targeting the inhibitory KIR and CD8 expressed on regulatory CD8 T cells.

By acting early in the autoimmune disease process, the drug aims to suppress and remove pathogenic cells, reduce downstream inflammation and avoid tissue damage.

Based in Seattle, Washington, Mozart Therapeutics aims to develop first-in-class disease-modifying therapies that treat autoimmune diseases by targeting the CD8 T regulatory network.

Mozart Therapeutics chief medical officer Jason Chien said: “Following completion of the Phase 1a portion, we expect to generate proof-of-mechanism data across two mechanistically and clinically different autoimmune diseases, and hopefully demonstrate the potential for CD8 Treg biology to be broadly relevant.”