BOSTON — Mediar Therapeutics has announced that the first patient has been dosed in its Phase 2 clinical trial evaluating MTX-463, a novel treatment for idiopathic pulmonary fibrosis (IPF). The trial, named WISPer, aims to assess the efficacy, safety, and tolerability of the investigational drug over a 24-week period, with the primary endpoint measuring changes in forced vital capacity (FVC), a key indicator of lung function.
MTX-463 is a first-in-class antibody that targets WISP1, a protein implicated in fibrosis progression. The drug is designed to inhibit the activity of myofibroblasts—cells central to the scarring process in IPF. The condition is a rare, progressive lung disease that causes irreversible tissue damage, leading to worsening respiratory function. Median survival following diagnosis is just three to five years, underscoring the urgent need for new therapeutic options.
“Dosing the first patient in the WISPer trial is a crucial step in exploring more effective treatments for IPF,” said Dr. Toby Maher, Director of Interstitial Lung Disease at the University of Southern California and lead investigator of the study. “We hope MTX-463 will provide a new avenue for slowing or stopping disease progression.”
The randomized, double-blind, placebo-controlled study is being conducted at multiple sites and follows a successful Phase 1 trial. The Phase 2 program is part of a global licensing collaboration with Eli Lilly, announced earlier this year, to support further clinical development of MTX-463.
“This milestone marks the beginning of a promising new chapter in IPF treatment,” said Dr. Jeff Bornstein, Chief Medical Officer at Mediar. “We’re thankful to our investigators and early enrollees, and we’re eager to continue enrolling patients in the coming months.”
In addition to MTX-463, Mediar is advancing two other fibrosis-focused therapies. MTX-474, which targets EphrinB2 signaling, recently completed its Phase 1 study and is expected to enter Phase 2 trials for systemic sclerosis in late 2025. A third program, targeting SMOC2 in renal fibrosis, is on track to nominate a clinical candidate by midyear.
MTX-463 works by neutralizing WISP1, a protein that has been shown to correlate with disease severity in IPF and can be tracked via blood biomarkers. Preclinical data demonstrated that blocking WISP1 effectively reduced fibrotic signaling and tissue scarring, supporting the drug’s progression into human trials.
The Phase 2 trial is now open to eligible participants and is registered under clinical trial ID NCT06967805.
