Mediar Therapeutics Doses First Patient in Phase 2 WISPer Trial of MTX-463 for Idiopathic Pulmonary Fibrosis

First-in-class agent targets WISP1 in patients with IPF

Primary endpoint in WISPer trial is change in Forced Vital Capacity (FVC) at 24 Weeks

BOSTON, June 5, 2025 /PRNewswire/ -- Mediar Therapeutics, Inc., a clinical-stage biotechnology company advancing first-in-class therapies designed to halt fibrosis, today announced the first patient has been dosed in its Phase 2 WISPer clinical trial evaluating MTX-463, an investigational therapy for idiopathic pulmonary fibrosis (IPF). The study's primary endpoint is the change from baseline in forced vital capacity (FVC)—an important measure of lung function—at 24 weeks. The study aims to advance the development of a potential novel treatment for patients living with IPF, and targets the myofibroblast, the key pathogenic cell in fibrosis. Mediar recently entered into a global licensing agreement with Lilly to advance MTX-463 through the Phase 2 WISPer trial.

IPF is a rare and progressive lung disease characterized by scarring and thickening of lung tissue, which leads to increasing shortness of breath and a persistent dry cough. Despite available treatments, there remains a high unmet medical need, with an average life expectancy of three to five years post-diagnosis. The WISPer trial is a randomized, double-blind, placebo-controlled 24-week Phase 2 study designed to evaluate the efficacy, safety, and tolerability of MTX-463 in patients living with IPF.

"Dosing the first patient in the WISPer trial represents an important step forward in the pursuit of new options to address the urgent needs of individuals living with IPF," said Toby Maher, MD, PhD, Director of Interstitial Lung Disease, University of Southern California, and lead investigator in the Phase 2 clinical study. "IPF is a devastating disease with limited treatment options. We are eager to evaluate the potential of MTX-463 to slow or halt disease progression and look forward to the insights this study will provide for patients and their physicians."

"Today marks an important milestone in our ongoing commitment to pioneering novel therapies to impact people living with fibrotic diseases. We extend our gratitude to Dr. Ryan Klein and the dedicated team at NewportNativeMD whose expertise and collaboration have been instrumental in reaching this important step," said Jeff Bornstein, MD, Chief Medical Officer, Mediar. "The first patient dosed with this first-in-class anti-fibrotic marks the beginning of a new chapter in our research, and we look forward to working with our clinical sites as we continue to enroll the Phase 2 program."

Mediar is also independently advancing its two wholly owned programs to treat other fibrotic disorders. MTX-474, a first-in-class human IgG1 antibody designed to neutralize EphrinB2 signaling, recently completed its Phase 1 clinical study. Mediar anticipates initiating a Phase 2 trial for MTX-474 in systemic sclerosis in the second half of 2025. Mediar's third novel fibrosis program, targeting SMOC2 for renal fibrosis, is also advancing with a plan to nominate a clinical candidate in the first half of 2025.

About MTX-463

MTX-463 is a first-in-class human IgG1 antibody developed against WNT1-inducible signaling pathway protein-1 (WISP1). WISP1 is a secreted matricellular protein shown to have a relevant role in fibrosis progression, is measurable in human blood, and correlates with disease severity. Data indicates that MTX-463 neutralizes WISP1-mediated fibrotic signaling and significantly reduced fibrosis in vitro and in various preclinical models. A Phase 1 study was recently completed and a Phase 2 study in patients with IPF is now open (NCT06967805). More information can be found at: wispertrial.com

About Mediar Therapeutics

Mediar Therapeutics is pioneering a new approach to fibrosis treatment that aims to halt the disease at a different source – the myofibroblast, the key pathogenic cell in fibrosis that drives scarring, disease progression, and ultimately organ failure. Mediar was founded based on a deep understanding of the complex science underlying fibrosis progression. By combining novel targets with reliable, easily detectable blood biomarkers and familiar modalities, Mediar's goal is to bring forward novel anti-fibrotic therapies that potentially have a precision medicine approach. For more information, contact [email protected] or follow us on LinkedIn.

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