Mediar Therapeutics Enters into Global Licensing Agreement with Lilly to Advance First-in-Class WISP1 Antibody for the Treatment of Idiopathic Pulmonary Fibrosis (IPF)

Mediar to advance MTX-463 through an IPF Phase 2 trial, with expected initiation in 1H 2025

BOSTON, Jan. 10, 2025 /PRNewswire/ -- Mediar Therapeutics, Inc., a clinical stage biotechnology company advancing a portfolio of first-in-class therapies designed to halt fibrosis progression, announced a global licensing agreement with Eli Lilly and Company 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 was recently completed in healthy volunteers and 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 initiate in the first half of 2025 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.

"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."

Under the terms of the agreement 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. Additionally, Mediar is eligible to receive high-single to low-double digit royalty payments and net sales milestones based on potential future product sales.

"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."

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. Mediar's third novel fibrosis program, targeting SMOC2, is also advancing with a plan to nominate a clinical candidate in the first half of 2025.

About MTX-463

MTX-463 is a first-in-class human IgG1 antibody developed against WNT1-inducible signaling pathway protein-1 (WISP1). WISP1 is a secreted matricellular protein shown to have a relevant role in fibrosis progression, measurable in human blood, and correlates with disease severity. Initial data indicates that MTX-463 neutralizes WISP1-mediated fibrotic signaling that spans several fibrotic indications and significantly reduced fibrosis in vitro and in preclinical mouse models. Mediar expects to initiate a Phase 2 study in IPF with MTX-463 in 1H-2025.

About MTX-474

MTX-474 is a first-in-class human IgG1 antibody designed to neutralize the EphrinB2 signaling that causes the onset and progression of fibrosis. Ephrin ligands and Eph receptors mediate biological processes involved in tissue fibrosis including cell migration, myofibroblast activation, and tissue remodeling. A growing body of evidence has implicated EphrinB2 in the fibrosis of the skin, lungs, and heart. Expression of EphrinB2 and its receptors are measurable in human blood and correlates with disease severity. Mediar expects to initiate a Phase 2 study in SSc with MTX-474 in 2H-2025.

About Mediar Therapeutics

Mediar Therapeutics is pioneering a new approach to fibrosis treatment that aims to halt the disease at a different source – the myofibroblast, the key pathogenic cell in fibrosis that drives scarring, disease progression, and ultimately organ failure. Mediar was founded based on a deep understanding of the complex science underlying fibrosis progression. By combining novel targets with reliable, easily detectable blood biomarkers and familiar modalities, Mediar's goal is to bring forward novel anti-fibrotic therapies that potentially have a precision medicine approach. For more information, contact [email protected] or follow us on LinkedIn.

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SOURCE Mediar Therapeutics