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Mediar plans to progress MTX-463 into a Phase 2 trial for idiopathic pulmonary fibrosis (IPF), which is anticipated to begin in the first half of 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.
"According to Rahul Ballal, Ph.D., the Chief Executive Officer of Mediar Therapeutics, 'This partnership enhances our distinctive myofibroblast-directed strategy for addressing fibrotic diseases and aligns with our goal of delivering first-in-class treatments to patients with significant unmet medical needs. We are thrilled to merge Lilly's unmatched proficiency in developing transformative medicines with our innovative scientific methodologies, as we progress a strong Phase 2 IPF initiative and work towards introducing new therapies that can stop fibrosis in its tracks.'"
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."
In addition to MTX-463, Mediar is set to further develop two of its fully owned programs aimed at treating fibrotic disorders. MTX-474 is a groundbreaking human IgG1 antibody engineered to inhibit the EphrinB2 signaling pathway responsible for fibrosis, and it is currently nearing the completion of a Phase 1 clinical trial. Mediar expects to launch a Phase 2 trial for MTX-474 in systemic sclerosis during the latter half of 2025. Furthermore, Mediar's third innovative fibrosis program, which focuses on SMOC2, is progressing as planned, with intentions to identify a clinical candidate in the first half of 2025.
Information on 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.
MTX-474 is a compound that has garnered attention in the field of pharmaceutical research. It is being investigated for its potential therapeutic effects and mechanisms of action. Researchers are particularly interested in its efficacy, safety profile, and how it interacts with various biological pathways. Ongoing studies aim to determine its viability as a treatment option for specific medical conditions, and early findings suggest promising results that could lead to further clinical development. As research progresses, more detailed insights into MTX-474's applications and benefits are expected to emerge.
MTX-474 is an innovative human IgG1 antibody that targets and neutralizes EphrinB2 signaling, which is known to trigger and advance fibrosis. The interactions between Ephrin ligands and Eph receptors play a crucial role in various biological processes associated with tissue fibrosis, such as cell movement, activation of myofibroblasts, and remodeling of tissues. Increasing evidence suggests that EphrinB2 is involved in the fibrosis affecting the skin, lungs, and heart. The levels of EphrinB2 and its receptors can be detected in human blood and are linked to the severity of the disease. Mediar plans to commence a Phase 2 clinical trial with MTX-474 for systemic sclerosis (SSc) in the second half of 2025.
Mediar Therapeutics is a biopharmaceutical company focused on developing innovative therapies to address unmet medical needs. By leveraging cutting-edge research and advanced technologies, Mediar aims to create effective treatments for various diseases. The company's commitment to scientific excellence and patient-centered approaches drives its mission to improve health outcomes and enhance the quality of life for patients around the world.
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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