Mediar Completes Enrollment in Phase 2 WISPer Trial of MTX-463 for IPF

Trial design and enrollment

The WISPer trial is a randomized, double-blind, placebo-controlled Phase 2 study that evaluates the safety and efficacy of MTX-463 in people with IPF. The company says the global study enrolled 168 adults, with sites spanning North and South America, Europe and Australia.

Participants were randomized to receive either MTX-463 or a matching placebo by intravenous infusion every four weeks for 24 weeks. The primary endpoint is the change in forced vital capacity (FVC), a measure of lung function, from baseline to Week 24.

Exploratory endpoints include an assessment of treatment effects in participants who are taking background IPF medications, as well as an analysis of treatment effects on blood-based biomarkers.

Jeff Bornstein, MD, Chief Medical Officer of Mediar Therapeutics, said that completing enrollment ahead of schedule "brings us meaningful steps closer to understanding the potential of MTX-463 for people living with IPF."

The science behind MTX-463

MTX-463 is a first-in-class human IgG1 antibody directed against WNT1-inducible signaling pathway protein-1 (WISP1). According to Mediar, WISP1 is a secreted matricellular protein that plays an important role in fibrosis progression and correlates with disease severity. It is also measurable in human blood.

The company states that data indicate MTX-463 neutralizes WISP1-mediated fibrotic signaling and significantly reduces fibrosis in vitro and in various preclinical models. The Phase 2 study builds on Phase 1 results in healthy volunteers, in which MTX-463 was well tolerated and demonstrated target engagement, according to Mediar.

Bornstein described IPF as a disease with "significant unmet need" and said the company believes its myofibroblast-directed approach "has the potential to address fibrosis at its source." Mediar describes the myofibroblast as the key pathogenic cell in fibrosis, driving scarring, disease progression and ultimately organ failure.

Lilly agreement and wider pipeline

Mediar is running the WISPer study under a global licensing agreement with Eli Lilly and Company. After the Phase 2 study is complete, Lilly will have the right to lead all further clinical development and commercialization of the program.

The company is also advancing other fibrosis programs:

• MTX-474, an EphrinB2-targeting antibody in Phase 2 development for systemic sclerosis. A Phase 1 study was recently completed and the Phase 2 study is now open.
• MTX-439, an anti-SMOC2 antibody in Phase 1 development for fibrosis associated with chronic kidney disease. The Phase 1 trial includes healthy participants and adults with diabetic kidney disease, with plans to move to a randomized Phase 2 program with clinical endpoints.

Mediar is also working on novel fibro-inflammatory targets as part of a recently announced collaboration with Ono Pharmaceutical.

What it means

Full enrollment means the WISPer study now moves toward its 24-week treatment period and the readout of its FVC endpoint. The source gives no date for results. The outcome will matter for Mediar and for Lilly, which holds the right to take over later development and commercialization after Phase 2. The trial is registered as NCT06967805, and further information is available at www.wispertrial.com.