Mozart Therapeutics Begins Phase 1a/b Trial Dosing for Autoimmune Drug MTX-101

Mozart Therapeutics, a biopharmaceutical company specializing in CD8 Treg modulators for autoimmune diseases, has commenced dosing for its initial clinical study of MTX-101. MTX-101, a groundbreaking CD8 Treg modulator and autoimmune checkpoint inhibitor, is undergoing its first Phase 1a/b clinical trial. This event marks a significant advancement in Mozart Therapeutics' efforts to pioneer new treatments for autoimmune conditions.

Katie Fanning, President and CEO of Mozart Therapeutics, emphasized the importance of this milestone, noting that the commencement of participant dosing signifies the company's transition into clinical stages. Fanning highlighted the potential of MTX-101 to revolutionize autoimmune disease treatment by targeting fundamental immune system dysfunctions. In autoimmune diseases, CD8 Treg cells often fail to regulate and eliminate harmful CD4 T cells, which leads to inflammation and tissue damage. MTX-101 aims to correct this by restoring immune balance and targeting the root causes of autoimmune dysregulation.

The clinical study consists of two parts: Phase 1a and Phase 1b. Phase 1a is designed as a single and multiple ascending dose escalation study focusing on the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MTX-101 in healthy adults. Phase 1b, on the other hand, is a multi-center, randomized, double-blind, placebo-controlled trial that will assess the safety, PK, PD, and disease-specific biomarkers in patients with type 1 diabetes mellitus or celiac disease.

Dr. Jason Chien, Chief Medical Officer at Mozart Therapeutics, highlighted the goals of the trial, which include thoroughly characterizing the novel approach to restoring immune balance and addressing the urgent need for safer and more effective treatments for chronic autoimmune conditions. He expressed optimism that, upon completion of Phase 1a, the company would achieve proof-of-mechanism data from two distinct autoimmune diseases, further validating the broad applicability of CD8 Treg biology.

MTX-101 operates as a bispecific antibody targeting inhibitory KIR and CD8 molecules on regulatory CD8 T cells. As an autoimmune checkpoint inhibitor, MTX-101 seeks to restore the natural functions of regulatory CD8 T cells. By intervening early in the autoimmune process, it aims to suppress and eliminate harmful cells, reduce inflammation, and prevent tissue damage.

Mozart Therapeutics is dedicated to developing pioneering disease-modifying therapies for autoimmune diseases. The company leverages a unique approach that focuses on re-establishing immune system functionality through the CD8 T regulatory network. Headquartered in Seattle, WA, Mozart Therapeutics continues to push forward in its mission to bring innovative treatments to patients suffering from autoimmune conditions.

With the initiation of this clinical trial, Mozart Therapeutics is taking a crucial step towards transforming the landscape of autoimmune disease treatment. The outcomes of these studies will be pivotal in determining the future direction of MTX-101 and its potential to become a cornerstone therapy for autoimmune diseases.