Crohn’s Disease

NordicIBDTrace™

Crohn’s disease 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.

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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™, VICM) 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.

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Precision biomarkers optimizing drug efficacy in Crohn’s disease

Changes from baseline in composite biomarker levels associated with neutrophil activity, type III collagen turnover, basement membrane degradation, and T-cell activity are directly tied to mucosal damage and immune response in Crohn’s disease.

Patients receiving placebo or non-efficacious treatments show minimal to slightly positive changes from baseline, indicating either biological inertia or disease progression. In contrast, kinase inhibitors, JAK inhibitors (JAKi), and anti-TNFα therapies demonstrate pronounced and sustained reductions in these biomarker composites—approximately 20–25% by week 52—signifying robust pharmacodynamic effects.

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.

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Precision biomarkers evaluating treatment response in Crohn’s disease

Nordic’s biomarker panels are efficient at evaluating treatment response in Crohn’s disease, leveraging markers of immune cell activation and matrix remodeling.

Baseline levels of biomarkers nordicCPa9-HNE™ and VICM (neutrophil and macrophage activity), C3M/nordicPRO-C3™ (type III collagen turnover), and C4M and C7M (MMP-mediated collagen degradation), differentiate responders from non-responders prior to treatment initiation. Non-responders exhibit significantly higher biomarker concentrations at baseline, while responders show lower initial levels and a declining trend, suggesting these markers have predictive utility in stratifying patient populations.

Our biomarkers also monitor response to treatment, with a reduced biomarker trajectory over time that is associated with clinical response. Specifically, responders demonstrate a marked decrease in levels of C3M, C4M, C7M, and nordicCPa9-HNE™ from baseline to day 56, whereas non-responders maintain elevated or increasing levels. The divergence indicates that these biomarkers can serve as dynamic indicators of pharmacodynamic engagement and therapeutic efficacy.

These biomarkers offer a mechanism to identify likely responders, refine inclusion criteria, and monitor treatment effectiveness longitudinally, facilitating more informed internal decision-making and enhancing the efficiency of clinical trials for Crohn’s disease.

Translational biomarkers to advance anti-Inflammatory drug development in CD

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.

About Crohn’s disease (CD)

  • Biomarkers in Crohn’s disease are measurable biological indicators used to assess inflammation, mucosal damage, and fibrosis. They help monitor disease activity, predict treatment response, and improve patient stratification in both clinical practice and research.

  • Yes, non-invasive blood-based biomarkers—such as CPa9-HNE, C3M, and PRO-C3—can reflect inflammation and tissue remodeling, providing valuable information without the need for frequent endoscopic procedures. This improves patient comfort and compliance while supporting ongoing disease monitoring.

  • Extracellular matrix (ECM) biomarkers, like C3M and PRO-C6, capture the dynamic turnover of collagen and other matrix proteins. They provide insight into structural changes in intestinal tissue, helping to evaluate disease progression and response to anti-inflammatory or anti-fibrotic therapies.

  • Biomarkers help identify pharmacodynamic effects of investigational therapies and differentiate responders from non-responders. They also enhance trial design by supporting patient selection, monitoring treatment response, and offering a mechanistic understanding of how a drug works.

  • Nordic IBDTrace™ is a biomarker panel developed by Nordic Bioscience that quantifies inflammation, mucosal injury, and fibrotic processes in IBD. In Crohn’s disease, it supports non-invasive disease assessment, patient stratification, and drug development by providing real-time data on tissue remodeling and immune activity.

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