Mediar and Lilly Partner on WISP1 Antibody for IPF Treatment

Mediar Therapeutics, a clinical-stage biotechnology firm based in Boston, has signed a global licensing agreement with Eli Lilly and Company. This agreement aims to develop MTX-463, a pioneering human IgG1 antibody, into a Phase 2 clinical trial for idiopathic pulmonary fibrosis (IPF). This drug is engineered to counteract WISP1-mediated fibrotic signaling, which is linked to various severe diseases. Results from the recently concluded Phase 1 trial involving healthy participants indicated that MTX-463 is well-tolerated and successfully engages the target, WISP1, at all tested dosages.

The upcoming Phase 2 trial, which Mediar plans to commence in the first half of 2025, will focus on assessing the safety, pharmacokinetics, and efficacy of MTX-463 in IPF patients. Upon the successful completion of this trial, Eli Lilly will assume responsibility for further clinical development and potential commercialization of the treatment.

Rahul Ballal, Ph.D., CEO of Mediar Therapeutics, expressed enthusiasm about the partnership. He highlighted how this collaboration aligns with Mediar's innovative myofibroblast-targeted approach to treating fibrotic diseases. Ballal emphasized the mutual benefits of combining Lilly's vast experience in delivering transformative medications with Mediar's cutting-edge scientific research. This partnership aims to advance the Phase 2 IPF program and potentially introduce new treatments capable of halting fibrosis.

Under the terms of the agreement, Mediar will receive $99 million, which includes an upfront payment and early-stage milestones. Additionally, Mediar stands to gain up to $687 million based on future development and commercialization milestones, along with royalties and sales milestones tied to future product sales.

Mark Genovese, M.D., senior vice president of Lilly Immunology development, praised Mediar's scientific approach and the creation of potentially groundbreaking therapies for fibrotic diseases, including MTX-463. He emphasized the collaboration as a testament to Lilly's commitment to fostering innovation and expressed optimism about advancing MTX-463 in partnership with Mediar to offer a new treatment option for IPF patients.

In addition to MTX-463, Mediar is independently progressing two other proprietary programs targeting fibrotic disorders. MTX-474, another groundbreaking human IgG1 antibody, is designed to neutralize EphrinB2 signaling responsible for fibrosis and is currently finishing a Phase 1 clinical trial. Mediar plans to commence a Phase 2 trial for MTX-474 in treating systemic sclerosis in the latter half of 2025. The third project focuses on targeting SMOC2, with plans to nominate a clinical candidate by early 2025.

MTX-463 is specifically developed against WNT1-inducible signaling pathway protein-1 (WISP1), a protein associated with fibrosis progression and detectable in human blood. Preliminary data suggest that MTX-463 effectively neutralizes fibrotic signaling linked to several conditions and significantly reduces fibrosis in laboratory and preclinical mouse studies.

MTX-474 targets EphrinB2 signaling, which contributes to tissue fibrosis processes such as cell migration and tissue remodeling. Evidence suggests EphrinB2's involvement in fibrosis affecting the skin, lungs, and heart, and its expression correlates with disease severity, measurable in human blood.

Mediar Therapeutics is at the forefront of developing innovative approaches to treating fibrosis, focusing on myofibroblasts, key cells driving disease progression and organ damage. Founded on an intricate understanding of fibrosis science, Mediar is dedicated to introducing novel therapies that offer a precision medicine approach through the identification of new targets and reliable biomarkers.