BOSTON, Mass. | June 23, 2026
Mediar Therapeutics has announced that the first cohorts have been dosed in its Phase 1 clinical trial evaluating MTX-439, a first-in-class monoclonal antibody targeting SMOC2 for the treatment of fibrosis associated with chronic kidney disease (CKD). The investigational therapy is designed to address one of the underlying causes of kidney disease progression by deactivating myofibroblasts, the cells responsible for excessive scar tissue formation. The randomized, double-blind, placebo-controlled study will assess the safety, tolerability, and pharmacokinetics of MTX-439 in healthy volunteers and adults with diabetic kidney disease (DKD). As the third anti-fibrotic program from Mediar to enter clinical development, MTX-439 strengthens the company’s pipeline of first-in-class therapies aimed at halting and reversing fibrosis across multiple chronic diseases.
MTX-439 Targets SMOC2 to Address Kidney Fibrosis
MTX-439 is a human IgG1 monoclonal antibody developed to neutralize SMOC2, a secreted matricellular protein increasingly recognized as a key driver of kidney fibrosis. Elevated SMOC2 expression has been shown to correlate with disease severity in chronic kidney disease, making it both a promising therapeutic target and a potential precision biomarker. By blocking SMOC2-mediated profibrotic signaling, the therapy aims to reduce scar formation and preserve kidney function. Preclinical studies demonstrated that MTX-439 significantly reduced fibrosis in human disease models, supporting its progression into clinical evaluation. Since diabetes remains one of the leading causes of CKD worldwide and there are currently no curative therapies available, Mediar believes targeting the biological mechanisms responsible for fibrosis may offer a new disease-modifying treatment strategy.
Phase 1 Study Evaluates Safety While Preparing for Phase 2
The ongoing Phase 1 clinical trial (NCT07473323) is evaluating MTX-439 in both healthy participants and patients with diabetic kidney disease, with primary objectives focused on safety, tolerability, and pharmacokinetics. Successful completion of this early-stage study is expected to support a randomized Phase 2 clinical program incorporating efficacy endpoints in patients with CKD-related fibrosis. Alongside the clinical milestone, Mediar Therapeutics has expanded its Clinical Advisory Board by appointing internationally recognized nephrology experts from Harvard Medical School, the University of Michigan, the University of Toronto, and the University of Leicester. The newly formed advisory group will help guide the clinical development strategy for MTX-439, particularly its planned Phase 2a studies in patients with diabetic kidney disease.
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Expanding Pipeline Strengthens Mediar’s Fibrosis Strategy
With MTX-439 entering the clinic, Mediar Therapeutics now has three first-in-class anti-fibrotic therapies advancing through clinical development. The company’s pipeline also includes MTX-474, an anti-EphrinB2 antibody currently in Phase 2a for systemic sclerosis (SSc), and MTX-463, a WISP1-targeting antibody being evaluated in Phase 2 for idiopathic pulmonary fibrosis (IPF) under a global partnership with Eli Lilly and Company. Mediar continues to expand its research pipeline with bispecific antibody programs designed to combine novel anti-fibrotic targets with established therapeutic pathways across multiple diseases. By focusing on therapies that directly target the myofibroblast, the central driver of tissue scarring and organ failure, the company aims to develop innovative treatments capable of slowing or reversing fibrosis in kidney, lung, skin, and other chronic diseases with significant unmet medical need.
Source: Mediar Therapeutics press release
