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The planned Phase 2 trial in IPF will focus on assessing MTX-463’s safety, pharmacokinetics, and efficacy.
Mediar Therapeutics, Inc, has entered into a global licensing agreement with Eli Lilly and Company to develop MTX-463 as a potential treatment for idiopathic pulmonary fibrosis (IPF), with a Phase 2 clinical trial set to begin in the first half of 2025, according to a Mediar news release.1
MTX-463 targets WISP1, a matricellular protein associated with fibrotic signaling pathways. By binding to and neutralizing WISP1, MTX-463 aims to halt the progression of fibrosis that can lead to reduced pulmonary function in conditions such as IPF. In a recently completed Phase 1 trial in healthy volunteers, MTX-463 was reported to be well tolerated and to engage WISP1 at all tested doses.
The planned Phase 2 trial in IPF will focus on assessing MTX-463’s safety, pharmacokinetics, and efficacy. Mediar expects to initiate the study in the first half of 2025 and will oversee its conduct. Upon completion of the Phase 2 trial, Lilly will have the right to assume responsibility for further clinical development and potential commercialization of the therapy.
"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."1
"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."1
Following completion of the Phase 2 study, Eli Lilly and Company will have the option to lead subsequent clinical development and commercialization of MTX-463. Mediar Therapeutics will retain rights to two additional programs, MTX-474 and a third agent targeting SMOC2, each intended for the treatment of various fibrotic disorders. MTX-474, which targets EphrinB2 signaling, is expected to begin a Phase 2 study for systemic sclerosis in the second half of 2025.
IPF is a progressive lung disease characterized by scarring of the lung tissue that impairs breathing. According to the American Lung Association, approximately 100,000 people in the United States live with IPF, and an estimated 30,000 to 40,000 new cases are diagnosed each year. IPF most often occurs in individuals between 50 and 70 years of age, commonly presenting with increasing dyspnea on exertion and a persistent dry cough.2
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