Mediar Therapeutics has achieved a significant milestone in fibrosis research by dosing the first patient in its Phase 2 WISPer clinical trial evaluating MTX-463, an investigational first-in-class therapy for idiopathic pulmonary fibrosis (IPF). The clinical-stage biotechnology company recently entered into a global licensing agreement with Eli Lilly and Company to advance this novel anti-fibrotic treatment through the Phase 2 study.
Novel Mechanism Targets Key Fibrosis Driver
MTX-463 represents a first-in-class human IgG1 antibody developed against WNT1-inducible signaling pathway protein-1 (WISP1), a secreted matricellular protein that plays a relevant role in fibrosis progression. The therapy targets the myofibroblast, identified as the key pathogenic cell in fibrosis that drives scarring, disease progression, and ultimately organ failure.
Preclinical data indicates that MTX-463 neutralizes WISP1-mediated fibrotic signaling and significantly reduced fibrosis in vitro and in various preclinical models. WISP1 is measurable in human blood and correlates with disease severity, potentially enabling a precision medicine approach to treatment.
Phase 2 Trial Design and Endpoints
The WISPer trial is designed as a randomized, double-blind, placebo-controlled 24-week Phase 2 study evaluating the efficacy, safety, and tolerability of MTX-463 in patients living with 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.
"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 at the 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."
Addressing Critical Unmet Medical Need
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.
"Today marks an important milestone in our ongoing commitment to pioneering novel therapies to impact people living with fibrotic diseases," said Jeff Bornstein, MD, Chief Medical Officer at 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."
Expanding Fibrosis Pipeline
Beyond the IPF program, Mediar is independently advancing two wholly owned programs targeting other fibrotic disorders. MTX-474, a first-in-class human IgG1 antibody designed to neutralize EphrinB2 signaling, recently completed its Phase 1 clinical study. The company anticipates initiating a Phase 2 trial for MTX-474 in systemic sclerosis in the second half of 2025.
Mediar's third novel fibrosis program targets SMOC2 for renal fibrosis and is advancing with plans to nominate a clinical candidate in the first half of 2025. The company's approach combines novel targets with reliable, easily detectable blood biomarkers and familiar modalities to develop anti-fibrotic therapies with potential precision medicine applications.
The company has secured significant financial backing with a $105 million financing, including an $85 million Series A round co-led by Novartis Venture Fund and Sofinnova Partners, with participation from multiple pharmaceutical companies including Pfizer Ventures, Bristol Myers Squibb, Eli Lilly & Company, and Ono Venture Investment.
