Mediar Therapeutics Partners with Eli Lilly for Phase II Trial of MTX-463 Targeting Pulmonary Fibrosis

On January 10, 2025, Mediar Therapeutics announced a significant global licensing agreement with pharmaceutical giant Eli Lilly and Company to advance MTX-463 into a Phase II clinical trial for the treatment of idiopathic pulmonary fibrosis (IPF). MTX-463 is a pioneering humanized IgG1 antibody designed to neutralize the fibrotic signaling pathway mediated by WISP1, potentially addressing multiple debilitating diseases.

The Phase I study has recently been completed in healthy volunteers, demonstrating good tolerability across all dosing levels and successful binding to WISP1. The upcoming Phase II trial aims to evaluate safety, pharmacokinetics, and efficacy in patients and is set to be conducted by Mediar in the first half of 2025. Following the completion of the Phase II study, Eli Lilly will have the authority to lead subsequent clinical development and commercialization efforts.

According to the terms of the BD&L agreement, Mediar will receive a total of $99 million, which includes an upfront payment and near-term milestone payments. Furthermore, Mediar could earn up to $687 million in potential regulatory and commercialization milestone payments. Additionally, Mediar will be eligible for royalties ranging from the high single digits to low double digits based on future product sales, as well as net sales milestone payments, bringing the total deal value to up to $786 million.

MTX-463 targets the WNT1-induced signaling pathway protein 1 (WISP1), a secreted extracellular matrix protein closely associated with the progression of fibrosis. Its levels can be measured in human blood and correlate with disease severity. Preliminary data indicate that MTX-463 effectively neutralizes various fibrotic signals mediated by WISP1, significantly reducing fibrosis in both in vitro experiments and mouse models. Mediar plans to initiate the Phase II trial for treating IPF in mid-2025.

In addition to Eli Lilly, the agreement involves early investments from notable biotech funds including Pfizer Ventures, Bristol Myers Squibb, Ono Pharmaceutical, and early-stage investment from Chinese firm Viya Bio.