PharmaNest, Mediar to Study MTX-474 for Scleroderma

PRINCETON, N.J., September 30, 2026 /CourierPR/ -- PharmaNest and Mediar Therapeutics have announced a collaboration to integrate advanced digital pathology into Mediar's ongoing Phase 2 clinical trial of MTX-474 in patients with diffuse cutaneous systemic sclerosis (dcSSc). The Phase 2 clinical trial, known as the EncompaSSc study, is evaluating the safety and efficacy of MTX-474, a first-in-class human IgG1 monoclonal antibody designed to neutralize EphrinB2 signaling, a pathway implicated in myofibroblast activation, extracellular matrix (ECM) deposition, and tissue remodeling known to drive fibrosis in systemic sclerosis (SSc).

MTX-474 is designed to intervene directly in biological pathways responsible for myofibroblast activation and pathological tissue remodeling, key contributors to fibrosis onset and progression in SSc. The collaboration between PharmaNest and Mediar Therapeutics will use PharmaNest's FibroNest™ AI-enabled digital pathology platforms to quantify and characterize the changes in the extracellular matrix (ECM) and fibrosis architecture within patient biopsies collected during the EncompaSSc study.

The primary efficacy endpoint of the EncompaSSc study is the mean change from baseline to week 24 in the modified Rodnan Skin Score (mRSS), an established clinical assessment of skin stiffness in people with SSc. Under the collaboration, PharmaNest will apply its FibroNest™ AI-enabled digital pathology platforms to skin biopsies collected during the EncompaSSc study. Spatial single-fiber analysis will quantify hundreds of fibrosis and ECM characteristics spatially and at the individual collagen-fiber level, and evaluate how these features and associated fibrotypes change following treatment with MTX-474.

The EncompaSSc Phase 2 study is a randomized, double-blind, placebo-controlled clinical trial evaluating MTX-474 in participants with diffuse cutaneous systemic sclerosis. Participants receive MTX-474 or placebo via intravenous infusion every four weeks over a 24-week period. The study also incorporates skin biopsies, molecular and transcriptomic analyses, serum biomarkers, imaging, and other clinical assessments to characterize treatment response. The EncompaSSc Phase 2 study is open and enrolling (NCT07287670). More information can be found at www.encompassctrial.com.

Mediar Therapeutics, a clinical-stage biotechnology company pioneering first-in-class therapies to halt and reverse fibrosis, is leading the EncompaSSc study. The study aims to deepen our understanding of the biological effects of MTX-474 in the EncompaSSc study.

PharmaNest, Inc., an AI-enabled digital pathology company specializing in the quantitative and spatial characterization of fibrosis and tissue remodeling, will apply its FibroNest™ AI-enabled digital pathology platforms to skin biopsies collected during the EncompaSSc study. The primary efficacy endpoint of the EncompaSSc study is the mean change from baseline to week 24 in the modified Rodnan Skin Score (mRSS), an established clinical assessment of skin stiffness in people with SSc. The study aims to provide quantitative spatial measures of fibrosis remodeling and potentially reveal tissue-level mechanisms associated with therapeutic response.

The collaboration between PharmaNest and Mediar Therapeutics will provide a deeper understanding of the biological effects of MTX-474 in the EncompaSSc study. The study aims to provide quantitative spatial measures of fibrosis remodeling and potentially reveal tissue-level mechanisms associated with therapeutic response. The collaboration will allow for a more comprehensive evaluation of the treatment's effects on the extracellular matrix and fibrosis architecture within patient biopsies.