Mediar Advances Fibrosis Portfolio to Phase 1 Trial and Forms Clinical Advisory Board

Mediar Therapeutics, Inc., a biotechnology firm specializing in groundbreaking fibrosis treatments, has announced the commencement of a Phase 1 trial for MTX-463 following the FDA's clearance of its investigational new drug (IND) application. The trial, which involves the initial cohort of participants, aims to evaluate the safety and tolerability of MTX-463, a novel human IgG1 antibody that neutralizes WISP-1-mediated fibrotic signaling, targeting Idiopathic Pulmonary Fibrosis (IPF) and other fibrotic conditions. This Phase 1 study will assess multiple dose levels, tolerability, pharmacokinetics, and the antibody's ability to engage its target, WISP-1. Healthy participants are being enrolled in staggered single ascending dose (SAD) and multiple ascending dose (MAD) cohorts.

Mediar's CEO, Rahul Ballal, Ph.D., highlighted the importance of this milestone, emphasizing the vision of the company's founders from Mass General Brigham and the efforts of the current team. He noted that MTX-463 is the first of two programs to begin clinical trials this year, with a second Phase 1 study for the anti-EphrinB2 molecule, MTX-474, scheduled to start in the third quarter.

To support the clinical development, Mediar has assembled a Clinical Advisory Board (CAB) consisting of globally recognized experts in fibrosis from various medical fields including pulmonology, rheumatology, hepatology, and regulatory sectors. The board's expertise will guide the progression of Mediar's pipeline to address the significant unmet needs in fibrosis treatment. Chief Medical Officer Jeff Bornstein, M.D., affirmed that the CAB's formation brings a wealth of knowledge crucial for advancing their clinical programs.

The newly appointed CAB members include:
- Flavia Castelino, M.D., Harvard Medical School, Massachusetts General Hospital
- Lara Dimick-Santos, M.D., CTI Clinical Trial & Consulting Services
- Scott Friedman, M.D., Icahn School of Medicine at Mount Sinai
- Robert Lafyatis, M.D., University of Pittsburgh Medical Center
- Rohit Loomba, M.D., University of California San Diego
- Toby Maher, M.D., University of Southern California
- Sydney Montesi, M.D., Harvard Medical School, Massachusetts General Hospital
- John Varga, M.D., University of Michigan

Upcoming presentations of new preclinical data include findings on MTX-463's application in IPF at the 2024 American Thoracic Society (ATS) meeting in San Diego, and MTX-474's relevance in Systemic Sclerosis (SSc) at the Congress on the EPH/Ephrin System in Parma, Italy.

MTX-463 is a first-in-class human IgG1 antibody targeting WNT1-inducible signaling pathway protein-1 (WISP-1), a protein involved in fibrosis progression and measurable in human blood. Initial studies indicate that MTX-463 effectively neutralizes WISP-1, reducing fibrosis in vitro and in preclinical mouse models. Currently, MTX-463 is undergoing Phase 1 clinical trials to ensure its safety and tolerability in healthy participants.

MTX-474, another first-in-class human IgG1 antibody by Mediar, aims to neutralize EphrinB2 signaling, which is implicated in the progression of various fibrotic diseases including those affecting the skin, lungs, and heart. The Phase 1 clinical studies for MTX-474 are expected to commence in the third quarter of 2024.

Mediar Therapeutics is at the forefront of developing innovative fibrosis treatments, focusing on the myofibroblast, a pathogenic cell central to fibrosis and organ failure. By combining novel targets with easily detectable biomarkers and well-understood therapeutic modalities, Mediar aims to streamline the development of effective fibrosis therapies.