Ulcerative Colitis

NordicIBDTrace™

Ulcerative colitis is characterized by chronic inflammation leading to progressive mucosal destruction and scar tissue formation through remodeling of the extracellular matrix (ECM).

The Nordic IBDTrace™ biomarker panel quantifies the degree of inflammation (nordicCPa9-HNE™, VICM), mucosal damage (e.g., C3M, C4M, C7M), and fibrotic processes (e.g., nordicPRO-C3™, nordicCTX-III™, nordicPRO-C6™) by measuring fragments of protease-mediated degradation of mucosal proteins released into the bloodstream.

The Nordic IBDTrace™ biomarker panel provides a blood-based approach to refine drug development strategies and accelerate the path to effective treatments. By offering mechanistic insights into ECM remodeling and immune cell activity, IBDTrace™ biomarkers improve patient stratification, support internal decision-making, and enhance overall efficiency in clinical trials.

Additionally, these biomarkers can help elucidate the mode of action of investigational therapies while serving as a non-invasive alternative to frequent procedures like endoscopy.

Mucosal damage and immune cell activity

Studies have shown that ECM remodeling precedes clinically apparent inflammation – therefore, biomarkers of mucosal damage and immune cell activity reflect intestinal barrier integrity, providing a comprehensive understanding of the pathological state of the tissue. By capturing these pathological changes, such biomarkers offer a valuable approach to accurately prognosticate disease course, serve as indicators of pharmacodynamic response, and monitor or predict response to therapeutics, supporting both clinical trial optimization and internal decision-making.

Biomarkers of immune cell activity (nordicCPa9-HNE™) and mucosal damage, such as the MMP-mediated degradation of type III, IV, and VII collagen (C3M, C4M, C7M), correlate with both clinical and endoscopic disease activity in ulcerative colitis, as assessed by UCEIS and the total Mayo score. Additionally, the ratio of type III collagen degradation to formation (C3M/nordicPRO-C3™) provides further insight into ECM turnover, offering a more comprehensive assessment of tissue remodeling. These biomarkers provide a non-invasive tool for monitoring disease progression and may support patient subgrouping, aiding in trial optimization strategies.

Precision biomarkers optimizing drug efficacy in ulcerative colitis

Nordic biomarkers present the pharmacodynamic effects of targeted therapies in ulcerative colitis. Biomarkers of neutrophil activity  (nordicCPa9-HNE­™), type III collagen turnover (C3M/nordicPRO-C3™), basement membrane degradation (C4M), and T-cell activity (C4G) enable comprehensive assessment of both short- and long-term pharmacodynamic response to targeted therapies such as S1PR modulators, anti-IL23 antibodies, and anti-α4β7 antibodies, capturing both immediate treatment effects and sustained mucosal healing. Additionally, these biomarkers can reflect disease worsening upon treatment withdrawal.

Over the 52-week treatment course, placebo and treatment-withdrawal (treatment-to-placebo) arms show minimal or reversed change from baseline, indicating either disease persistence or biological rebound following therapeutic cessation. In contrast, active treatments of S1PR modulators (S1Pi), anti-IL23, and anti-α4β7 antibodies demonstrate consistent, dose-dependent reductions in biomarker levels, with S1Pi showing the most pronounced effect by week 52, exceeding a 25% reduction from baseline.

Precision biomarkers evaluating treatment response in ulcerative colitis

Incorporating biomarkers of immune cell activity (nordicCPa9-HNE­™, VICM, C4G), MMP-mediated collagen degradation (C3MC4MC7M), and type III collagen turnover C3M/nordicPRO-C3™) into drug development strategies enables monitoring of treatment response, supporting internal decision-making and optimizing therapeutic efficacy.

By week 10, responders exhibit a sharp decline nearing 20% reduction from baseline in composite biomarker expression, indicative of rapid treatment engagement and early anti-inflammatory or tissue-stabilizing effects. This trend continues through week 52, reaching nearly a 35% reduction, consistent with sustained mucosal healing and remodeling.

In contrast, non-responders show minimal biomarker suppression, with only modest declines by week 10 that plateau by week 52. This indicates limited therapeutic impact at both the immunologic and extracellular matrix levels.

Translational biomarkers to advance anti-Inflammatory drug development in UC

Nordic Bioscience integrates translational models with clinically validated biomarkers to bridge preclinical and clinical research in drug development. Our ProteinFingerPrint™ biomarkers, including nordicPRO-C3™ and C3M, reflect tissue formation and degradation and are modulated by anti-inflammatory treatments.

By assessing these biomarkers across in-vitro models, in-vivo samples, and patient cohorts with gastrointestinal disease, we provide insights into drug-induced changes in tissue integrity, supporting target validation and elucidating mechanisms of action to refine therapeutic strategies.

Translational biomarkers in IBD

About ulcerative colitis (UC)

  • Biomarkers in ulcerative colitis provide measurable insights into inflammation, mucosal damage, and tissue remodeling. They help monitor disease activity, assess treatment response, and support clinical trial optimization with less reliance on invasive procedures like endoscopy.

  • Yes, biomarkers enable identification of patients likely to respond to specific therapies and help monitor response over time. This supports a precision medicine approach, improving treatment outcomes and reducing unnecessary exposure to ineffective treatments.

     

     

  • While not a direct replacement, blood-based biomarkers such as CPa9-HNE, C3M, and PRO-C3 offer a non-invasive alternative for tracking disease progression and treatment effects, improving patient compliance and supporting more frequent monitoring.

  • Extracellular matrix (ECM) biomarkers reflect tissue changes caused by inflammation and fibrosis. By measuring collagen degradation and formation, biomarkers like C3M and PRO-C3 offer insights into mucosal integrity and healing, which are critical for managing long-term disease.

  • Nordic IBDTrace™ is a panel of biomarkers developed to quantify immune activity, mucosal injury, and fibrotic remodeling in IBD. In ulcerative colitis, it supports patient stratification, pharmacodynamic assessment, and therapeutic decision-making in both clinical practice and research.

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    Nordic Bioscience’s assays and services are research use only products and services and do not qualify for medical or diagnostic purposes.