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Eli Lilly is one of a handful of Big Pharmas that secured a close look at Mediar Therapeutics through venture investments. \n Eli Lilly is making a play for the idiopathic pulmonary fibrosis (IPF) market, offering Mediar Therapeutics $99 million in upfront and near-term payments for global rights to an asset that is entering phase 2.The deal, which includes up to $687 million in milestones, gives Lilly global rights to the anti-WISP1 antibody MTX-463. Researchers have linked WISP1 to fibrosis progression, leading Mediar to identify the protein as a way to reduce scarring in IPF and other diseases driven by the accumulation of scar tissue. Mediar recently finished a phase 1 trial in healthy volunteers.With the study showing MTX-463 is well tolerated and engages WISP1, Lilly has swooped in to secure an asset that could unlock a market currently dominated by Boehringer Ingelheim’s Ofev and Roche’s Esbriet. Efforts to create next-generation products have largely ended in failure, although Boehringer reported a phase 3 win last year.Lilly has been an observer as other companies have swung and missed at IPF, but it does have some links to the indication. Endeavor BioMedicines is testing an ex-Lilly molecule in IPF. Morphic once had an IPF collaboration with AbbVie, but the biotech was focused on inflammatory bowel disease by the time Lilly bought it last year. The Mediar deal establishes Lilly as a player in the IPF space, albeit one that is further from market than some of the other runners and riders. Mediar plans to start a phase 2 trial of MTX-463 in the first half of 2025. The biotech will run the midphase trial and then hand over to Lilly for further development.Lilly is one of a handful of Big Pharmas that secured a close look at Mediar through venture investments. Bristol Myers Squibb, Lilly, Novartis Venture Fund, Ono Venture Investment and Pfizer Ventures invested in 2023 in the $105 million financing that positioned Mediar to enter the clinic. The funding reflected the potential for Mediar to deliver a first-in-class therapy that more precisely treats IPF than existing drugs.

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. Media Contact [email protected] SOURCE Mediar Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Boston-area startup Mediar Therapeutics is teaming up with Eli Lilly on a new drug for idiopathic pulmonary fibrosis. Lilly — one of the five large pharmas backing Mediar – will pay $99 million in combined upfront and near-term milestones as part of a new pact, the companies said Friday morning. The Indianapolis pharmaceutical behemoth is also promising up to $687 million more in development and commercialization biobucks to access the startup’s experimental drug, which neutralizes a fibrotic signaling pathway known as WISP-1. In the first half of this year, Mediar will start a Phase 2 of its human IgG1 antibody, dubbed MTX-463. The company will test the antibody in patients with IPF in about 15 countries, CEO Rahul Ballal told Endpoints News . After that, Lilly will have the option to take the candidate into Phase 3 development, the companies said. The partnership is the result of a competitive process that began around last year’s JP Morgan Healthcare Conference, Ballal said. The Lilly payments, which come after an $85 million Series A in March 2023, will help Mediar fund the mid-stage IPF trial and bring another in-house candidate into Phase 2 in the second half of this year, the company said. That second program is MTX-474, which neutralizes EphrinB2 signaling, and will be tested in patients with systemic sclerosis. A third pipeline program, going after SMOC2, is also in the works. “As you think about the matrix of when to fund, how to fund, and ultimately what you give away to fund those things, the Lilly deal hit all of those boxes,” Ballal said. The biotech has a little over 30 employees, he added. Idiopathic pulmonary fibrosis is a lung-scarring condition that can lead to death within about five years of diagnosis. Mediar’s second employee lost their father to the disease in 2022, chief scientific officer Paul Yaworsky previously told Endpoints . There are no disease-modifying drugs approved for the condition. The two FDA-approved medicines  — Roche’s Esbriet and Boehringer Ingelheim’s Ofev — slow the disease. Roche is considering selling its decade-old medicine. Meanwhile, Boehringer hopes to get another IPF drug approved soon, and multiple other biopharmas are looking to treat the condition. IPF appears to be a relatively new area for Lilly, which for the past few years has dominated headlines for its work in obesity, diabetes and Alzheimer’s, and has become the world’s most valuable drugmaker by market cap. Last fall, Lilly invested in Arda Therapeutics, an ADC startup that might go into pulmonary fibrosis and other similar areas, according to its CEO . Lilly might have had a chance in IPF years ago. One of the well-funded biotechs in the space, Endeavor BioMedicines , is developing an IPF drug that Lilly had tested for cancer but offloaded to another company before it landed at Endeavor.