Study to Evaluate MTX-101 for Safety,
Pharmacokinetics, and Pharmacodynamics in Healthy Adults and
Patients
SEATTLE, June 17,
2024 /PRNewswire/ -- Mozart Therapeutics, a
clinical stage biopharmaceutical company focused on the development
of CD8 Treg modulators in autoimmune diseases, today announce
the dosing of the first cohort of participants in the Company's
initial clinical study of MTX-101, a first-in-class CD8 Treg
modulator and autoimmune checkpoint inhibitor.
"Dosing the first cohort of participants in this Phase 1a/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," said
Katie Fanning, President and Chief
Executive Officer of Mozart Therapeutics. "In autoimmune disease,
CD8 Treg fail to recognize and eliminate pathogenic or
self-reactive CD4 T cells, resulting in downstream proinflammatory
events and perpetuation of tissue destruction. The aim of MTX-101
is to selectively target a fundamental cause of immune
dysregulation and restore immune homeostasis in autoimmune disease"
added Ms. Fanning.
The Phase 1a portion of the study (NCT06324604) is a single and
multiple ascending dose escalation study evaluating the safety,
pharmacokinetics (PK), and pharmacodynamics (PD) of MTX-101 in
healthy adults. The Phase 1b is a
prospective, multi-center, randomized, double-blind,
placebo-controlled trial to evaluate safety, PK, PD, and
disease-specific biomarkers in patients with type 1 diabetes
mellitus or celiac disease.
"While the goal of this trial is to carefully characterize the
profile of a novel approach to restoring immune homeostasis, we
also recognize the urgent need for safer, more effective targeted
approaches to preventing and treating chronic debilitating
autoimmune diseases. 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," said Dr. Jason
Chien, Chief Medical Officer at Mozart.
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.
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.
View original
content:https://www.prnewswire.com/news-releases/mozart-therapeutics-doses-first-cohort-of-participants-in-phase-1ab-clinical-trial-of-mtx101-in-development-for-treatment-of-autoimmune-diseases-302173782.html
SOURCE Mozart Therapeutics