Celiac Disease

Biomarkers for celiac disease (CeD)

Celiac disease leads to inflammation and damage to the intestinal lining upon interaction with immunogenic gluten peptides, impacting tissue architecture and therefore directly altering the extracellular matrix (ECM).

Biomarkers of MMP-mediated collagen degradation (C3M, C4M, C6M) and immune cell activity (C4G) offer insights into epithelial integrity and the extent of tissue damage. By capturing real-time changes in tissue architecture, these biomarkers enable a more precise assessment of disease activity, therapeutic response, and pharmacodynamic effects, optimizing drug development and supporting internal decision making.

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Biomarkers for monitoring disease activity and tissue integrity in CeD

Biomarkers of MMP-mediated collagen degradation (C3M, C4M, C6M), immune cell activity (C4G), and formation of type VII collagen (PRO-C7) reflect histological inflammation as assess by the Q-Marsh score.

These ECM biomarkers reflecting collagen remodeling and epithelial integrity offer a direct, non-invasive measure of tissue damage, complementing traditional symptom-based assessments and histology in CeD.

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Biomarkers for monitoring intestinal barrier integrity

Biomarkers of MMP-mediated collagen degradation (C3M, C4M, C6M), immune cell activity (C4G), and formation of type VII collagen (PRO-C7) correlate inversely with villus height, directly linking biomarker levels to changes in tissue architecture and intestinal barrier integrity.

This highlights their potential to go beyond traditional biomarkers of inflammation by providing a direct assessment of structural tissue damage. By integrating these biomarkers into clinical research, they can support drug development by enabling more precise evaluation of disease progression, and treatment efficacy, supporting clinical trial design and therapeutic decision-making.

Biomarkers for evaluating pharmacodynamic response

Biomarkers of MMP-mediated collagen degradation (C3M, C4M, C6M), immune cell activity (C4G), and formation of type VII collagen (PRO-C7) provide assessment of pharmacodynamic response to targeted therapies in CeD.

A decline in biomarker levels across both treatment arms, compared to an increase in the placebo group, reflects treatment-induced changes in intestinal tissue remodeling. This demonstrates the potential of these biomarkers for supporting pharmacodynamic evaluation and advancing the development of novel therapeutics for CeD.

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About celiac disease

  • Biomarkers in celiac disease are measurable indicators of biological processes such as inflammation and tissue damage caused by gluten exposure. They offer a non-invasive way to monitor disease activity, assess treatment response, and support drug development beyond traditional symptom-based assessments and biopsies.

  • Collagen biomarkers like C3M, C4M, and C6M reflect matrix metalloproteinase (MMP)-mediated degradation of the intestinal extracellular matrix, while PRO-C7 indicates type VII collagen formation. These markers provide insight into epithelial barrier integrity and real-time tissue remodeling, helping to assess disease severity and mucosal healing.

  • Yes, several serum biomarkers—including C3M, C4G, and PRO-C7—can detect gluten-induced damage non-invasively. These biomarkers track changes in tissue architecture and immune activity, offering a more convenient and objective method to monitor disease progression and treatment effects in clinical trials and research.

  • Biomarkers provide early, measurable indicators of therapeutic response by capturing pharmacodynamic changes in tissue remodeling. This helps optimize trial design, reduce reliance on repeated endoscopies, and identify responders more effectively, accelerating the development of new treatments.

  • Nordic Bioscience’s biomarkers are based on ProteinFingerPrint™ Technology, which quantifies specific fragments of collagen turnover and immune activity. This technology enables precise, tissue-level monitoring of inflammation and fibrosis in celiac disease, supporting more targeted and data-driven clinical research.

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