MTX-463 expected to enter Phase 2 testing in IPF in first half of 2025
Mediar Therapeutics signs global licensing deal with Eli Lilly for MTX-463
Mediar Therapeutics is planning to launch a Phase 2 clinical trial to test its experimental therapy MTX-463 in people with idiopathic pulmonary fibrosis (IPF).
The company has entered into a global licensing agreement with Eli Lilly to advance the development of MTX-463. Mediar will be responsible for conducting the Phase 2 trial. Then, once the Phase 2 study is complete, Lilly will have the right to lead further clinical development of MTX-463, and to commercialize the therapy if it is ultimately approved by regulators.
Mediar is expecting its Phase 2 IPF study to start in the first half of the year, but did not provide additional details on the trial’s expected design or timing.
“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,” Rahul Ballal, PhD, CEO of Mediar, said in a company press release.
IPF is marked by fibrosis, or scarring, in the lungs. When lung tissue is scarred, it’s harder for the lungs to fill up with air and take in oxygen, leading to symptoms like shortness of breath.
MTX-463 blocks activity of signaling molecule with role in fibrosis
MTX-463 is an antibody-based therapy that’s designed to halt the progression of fibrosis by blocking the activity of WNT1-inducible signaling pathway protein-1 (WISP1), a signaling molecule that’s been shown to play a role in fibrosis development. According to Mediar, this experimental strategy is expected to reduce the activity of fibrosis-promoting cells called myofibroblasts.
“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,” Ballal said.
Mediar has completed a Phase 1 study (NCT06401213) testing MTX-463 in healthy volunteers. Results showed the therapy was well tolerated and engaged with WISP1 at all tested doses, according to the company.
As part of the new deal with Lilly, Mediar will receive $99 million in upfront payments and near-term milestones. Mediar will also be eligible to receive up to another $687 million if certain development and commercialization milestones are met, as well as royalties on eventual sales of MTX-463.
“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, MD, senior vice president of immunology development at Lilly. “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.”
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