Eli Lilly and Company and Mediar Therapeutics have announced a global licensing agreement focused on developing a novel treatment for idiopathic pulmonary fibrosis (IPF). The collaboration will advance Mediar's MTX-463, a first-in-class human IgG1 antibody, into a Phase 2 clinical trial. MTX-463 is designed to neutralize WNT1-inducible signaling pathway protein-1 (WISP1), a key mediator of fibrotic signaling. The partnership aims to address the significant unmet medical need in IPF, a progressive and ultimately fatal lung disease characterized by scarring of the lung tissue.
Targeting Fibrosis with MTX-463
MTX-463 represents a novel approach to treating IPF by targeting WISP1, a secreted matricellular protein implicated in fibrosis progression. Preclinical data suggest that MTX-463 can neutralize WISP1-mediated fibrotic signaling, potentially reducing fibrosis in various fibrotic indications. A Phase 1 study in healthy volunteers demonstrated that MTX-463 was well-tolerated and effectively engaged WISP1 at all tested doses.
"This collaboration supports our unique myofibroblast-directed approach to treating fibrotic diseases and our mission to bring first-in-class therapies to patients with high unmet medical need," said Rahul Ballal, Ph.D., Chief Executive Officer of Mediar Therapeutics.
Clinical Trial Plans and Financial Terms
Under the terms of the agreement, Mediar will receive a combined $99 million, including an upfront payment and near-term milestones. Furthermore, Mediar is eligible to receive up to an additional $687 million in potential downstream development and commercialization milestones, as well as royalties on future product sales. Mediar will conduct the Phase 2 trial, expected to begin in the first half of 2025, to evaluate the safety, pharmacokinetics, and efficacy of MTX-463 in IPF patients. Following the Phase 2 study, Lilly will have the right to lead further clinical development and commercialization.
Broader Pipeline and Strategic Focus
Mediar continues to advance its other programs targeting fibrotic disorders, including MTX-474, an anti-EphrinB2 antibody currently in Phase 1, with a Phase 2 trial planned for systemic sclerosis in the second half of 2025. The company is also progressing a program targeting SMOC2, with plans to nominate a clinical candidate in the first half of 2025.
"Mediar’s scientific approach and experienced team has led to the creation of novel, potential first-in-class therapies for fibrotic diseases, including MTX-463," said Mark Genovese, M.D., senior vice president of Lilly Immunology development. "The collaboration with Mediar exemplifies our dedication to fostering innovation, and we look forward to partnering with the Mediar team to advance MTX-463 through development in hopes of bringing a novel treatment option to people living with IPF."
