BOSTON — Mediar Therapeutics, a clinical-stage biotechnology company developing treatments for fibrotic diseases, has completed enrollment in its Phase 2 WISPer clinical trial evaluating MTX-463, an experimental antibody therapy for idiopathic pulmonary fibrosis (IPF).
The global study enrolled 168 patients across more than 70 clinical sites in North America, South America, Europe and Australia, completing enrollment ahead of schedule.
MTX-463 is a first-in-class antibody designed to target WISP1, a protein associated with the development and progression of fibrosis, a condition characterized by excessive scar tissue formation.
“Completing enrollment in the WISPer trial ahead of schedule brings us meaningful steps closer to understanding the potential of MTX-463 for people living with IPF,” said Jeff Bornstein, MD, Chief Medical Officer of Mediar Therapeutics. “IPF remains a devastating disease with significant unmet need, and we believe our myofibroblast-directed approach has the potential to address fibrosis at its source.”
Idiopathic pulmonary fibrosis is a progressive lung disease that causes scarring of lung tissue, making breathing increasingly difficult and reducing lung function over time.
The randomized, double-blind, placebo-controlled WISPer study is evaluating the safety and effectiveness of MTX-463 in adults with IPF.
Participants receive either MTX-463 or a placebo through intravenous infusion every four weeks over a 24-week treatment period.
The study’s primary endpoint is the change in forced vital capacity, a key measure of lung function, from the beginning of treatment through Week 24.
Researchers will also evaluate treatment outcomes among patients receiving existing IPF medications and examine changes in blood-based biomarkers associated with the disease.
MTX-463 is a human IgG1 antibody developed to inhibit WNT1-inducible signaling pathway protein-1 (WISP1), which has been linked to fibrosis progression and disease severity.
Earlier Phase 1 testing in healthy volunteers showed that MTX-463 was generally well tolerated and demonstrated evidence of engaging its intended biological target.
Mediar is conducting the Phase 2 study under a global licensing agreement with Eli Lilly and Company. Following completion of the trial, Lilly will have the right to lead further clinical development and commercialization of the treatment.
Beyond MTX-463, Mediar is advancing several additional experimental therapies targeting fibrotic diseases.
Its pipeline includes MTX-474, an EphrinB2-targeting antibody undergoing Phase 2 development for systemic sclerosis, and MTX-439, an antibody targeting SMOC2 that is in Phase 1 development for fibrosis associated with chronic kidney disease.
The company is also pursuing additional treatments targeting fibro-inflammatory pathways through a research collaboration with Ono Pharmaceutical.
The WISPer trial remains ongoing, with researchers evaluating whether MTX-463 can slow or potentially reverse the progression of pulmonary fibrosis.
