Mediar Therapeutics, Inc., a clinical stage biotechnology company developing first-in-class therapies designed to halt fibrosis progression, signed a global licensing agreement with Eli Lilly and Co. to advance MTX-463 into a Phase 2 clinical trial for idiopathic pulmonary fibrosis (IPF). MTX-463 is a first-in-class human IgG1 antibody designed to neutralize WISP1-mediated fibrotic signaling in several debilitating diseases.

The Phase 1 study showed MTX-463 to be well-tolerated and engaged WISP1 at all tested doses. The Phase 2 IPF study is designed to evaluate safety, pharmacokinetics, and efficacy in patients. The trial is expected to begin 1H25 and will be conducted by Mediar. Following completion of the Phase 2 study, Lilly will have the right to lead all further clinical development and commercialization of the program.

Mediar will receive a combined $99 million, which is inclusive of an upfront payment and near-term milestones. Mediar may receive up to an additional $687 million in potential downstream development and commercialization milestones, as well as royalty payments and sales milestones based on potential future product sales.

Beyond MTX-463, Mediar will continue to independently advance its two wholly owned programs to treat fibrotic disorders. MTX-474 is a first-in-class human IgG1 antibody designed to neutralize the EphrinB2 signaling that causes fibrosis and is currently finishing a Phase 1 clinical study. Mediar anticipates initiating a Phase 2 trial for MTX-474 in systemic sclerosis in the second half of 2025.

“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. “By combining Lilly’s unparalleled expertise in bringing life-changing medicines to patients with our novel scientific approaches, we are excited to advance a robust Phase 2 IPF program and potentially bring new therapies that halt fibrosis.”

“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.”