Author: Claire Hornung

A Hallmark of Fibrosis Initiation and Mortality in Alcohol-Related Liver Disease

Posted on by Claire Hornung

Fibroblast activation assessed by PRO-C3 and PRO-C6 is associated to accumulation of key bile acids – A hallmark of fibrosis initiation and mortality in alcohol-related liver disease

Introduction

Alcohol-related liver disease (ALD) results from persistent liver damage due to excessive alcohol consumption. ALD promotes the disruption of bile acid homeostasis, further contributing for the development of liver fibrosis and disease progression to cirrhosis, and end-stage liver failure.

The use of anti-fibrotic therapy has shown to simultaneously reduce bile accumulation and levels of
fibroblast activity biomarker nordicPRO-C3™. However, the role of bile acids as drivers of fibrogenesis remains unclear. The present work aims to investigate the link between bile accumulation in ALD and fibrosis induction ALD by exploring associations between fibroblast activity biomarkers, bile acids, and clinical outcomes.

Poster

EASL2025 PRO-C3 and PRO-C6 in ALD_ Nordic BioscienceDownload

Conclusion

Increased circulating levels of toxic bile acids are associated to fibroblast activation and poor prognosis in ALD. The data presented suggests that bile acids are linked to activation of fibrogenesis and, therefore, may induce the development of liver fibrosis in ALD.

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    Fibroblast Activity Assessed by NordicPRO-C3™ is Prognostic for Fibrosis Progression in MASH

    Posted on by Claire Hornung

    Fibroblast activity assessed by PRO-C3 is prognostic for fibrosis progression in MASH patients treated with insulin sensitizer MSDC-0602K during a phase IIb clinical trial

    Introduction

    Liver fibrosis is a dynamic process driven by hepatic stellate and other mesenchymal cells forming ECM and disrupting normal organ architecture, while releasing ECM fragments into the bloodstream. These fragments are surrogates of ECM formation that can be leveraged as fibrosis biomarkers. In this study, we measured biomarkers of collagen type III and type VI (nordicPRO-C3™ and nordicPRO-C6™) during EMMINENCE, a phase IIb clinical trial testing MSDC-0602K, an insulin sensitizer in MASH patients.

    Poster

    EASL2025 PRO-C3 in MASH_Nordic BioscienceDownload

    Conclusion

    Lower fibroblast activity (nordicPRO-C3™) at baseline was associated with achieving primary endpoint as well as fibrosis regression, while higher baseline nordicPRO-C3™ was associated with fibrosis progression. MSDC-0602K significantly reduced nordicPRO-C3™ and nordicPRO-C6™, suggesting an anti-fibrotic and pro-metabolic effect. NordicPRO-C3™ can identify MASH patients who are likely to respond to treatment and prognosticate their evolution.

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      The Endotrophin Biomarker, NordicPRO-C6™, as a Marker for Intestinal Fibrosis in Crohn’s Disease

      Posted on by Claire Hornung

      Introduction

      Crohn’s disease (CD) is a chronic inflammatory condition that often progresses to fibrostenotic complications due to imbalanced extracellular matrix (ECM) remodeling. Fibrosis, a result of excessive ECM deposition, is challenging to manage as current treatments do not prevent or reverse these processes. Diagnostic tools are limited, as endoscopy only visualizes the mucosa and imaging struggles to distinguish fibrosis from inflammation. Type VI collagen is associated with fibrogenesis and is also expressed by adipocytes which may suggest that type VI collagen could also be associated with creeping fat in CD patients with fibrostenotic structures.

      This study aimed to evaluate the endotrophin marker, nordicPRO-C6™, and its ability to distinguish stenosing from luminal CD, predict postoperative recurrence, and correlation with histological fibrosis severity.

      Poster

      DDW2025 PRO-C6 in CD_Nordic BioscienceDownload

      Conclusion

      NordicPRO-C6™ as an ECM marker demonstrated potential in characterizing fibrosis in CD and distinguishing stenosing from luminal phenotype. Evidence from tissue samples suggested that increased collagen VI gene expression was associated with the development of complicated disease featuring strictures. NordicPRO-C6™ levels decreased following resection but returned to baseline by 3 months, which may indicate a risk of recurrent fibrosis formation. These findings highlight nordicPRO-C6™ as a promising non-invasive tool for monitoring disease stage and fibrosis. Extended follow-up studies are crucial to validate the clinical utility of nordicPRO-C6™ and to further explore its role in guiding personalized treatment strategies.

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        C3F Is a Potential Biomarker for Intestinal Fibrosis in Crohn’s Disease

        Posted on by Claire Hornung

        Fibroblast activation protein (FAP)- cleaved type III collagen (C3F) is a potential marker for intestinal fibrosis in patients with Crohn’s disease

        Introduction

        Crohn ‘s disease (CD) is characterized by chronic inflammation in the gut, where severe complications such as fibrotic strictures require surgical resection. Stricture development involves excessive extracellular matrix (ECM) deposition due to continuous activation of intestinal myofibroblasts, that further contribute to intestinal fibrogenesis. Emerging data suggests that stricture-related intestinal myofibroblasts overexpress a serine protease called fibroblast activation protein (FAP). Furthermore, type III collagen deposition is increased during fibrosis in all layers of the intestinal tract, and studies have shown elevated
        collagen degradation in serum from patients with CD.

        In this study we aimed to evaluate the potential of FAP-cleaved type III collagen (C3F) as a serum marker for intestinal fibrosis in CD.

        Poster

        DDW2025 C3F Intestinal Fibrosis_Nordic BioscienceDownload

        Conclusion

        C3F levels are elevated in patients with stenotic Crohn’s disease (CD) compared to those with luminal CD at baseline. In the stenotic group, C3F levels rise further following surgical resection compared to baseline, 1 month, 3 months, and 6 months post-surgery, suggesting that C3F reflects fibroblast activity during fibrostenosis and tissue remodeling following surgery. While C3F demonstrates only modest discriminatory ability across comparisons (AUC 0.65–0.69), its positive correlation with CRP supports an association with inflammation leading to collagen deposition and fibrosis in stenotic CD. Additionally, a negative correlation with disease duration suggests that C3F may reflect fibrosis at earlier stages of the disease.

        In luminal CD patients, C3F levels were significantly higher at 12 months than at baseline and 6 months. Moreover, early C3F levels (baseline, 3 months, and 6 months) were significantly associated with ileal stenosis observed at 12 months, suggesting that elevated C3F may predict future endoscopic disease activity or potential relapse. Overall, these findings underscore the potential of C3F as a novel biomarker for intestinal fibrosis in Crohn’s disease.

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          Investigating NordicPRO-C3™ as a Prognostic Biomarker in NSCLC Patients

          Posted on by Claire Hornung

          Fibroblast derived type III collagen pro-peptides (PRO-C3) in plasma are associated with outcome for patients with NSCLC treated with anti-PD1 plus chemotherapy

          Introduction

          Tumor fibrosis is essential for defining outcome of patients with various solid tumors including lung cancer. The cancer associated fibroblast (CAF) activation and increased deposition of type III collagen leads to immune exclusion and high interstitial pressure in the tumor microenvironment. Recently, FDA issued a Letter-of-Support to encourage use of the non-invasive tumor fibrosis biomarker nordicPRO-C3™ (type III collagen pro-peptides) in patients with solid tumors.

          In thi study we investigate nordicPRO-C3™ as a prognostic biomarker in patients with non-small cell lung cancer (NSCLC) treated with anti-PD1 + chemotherapy.

          Poster

          AACR2025 nordicPRO-C3™ in NSLC patients_Nordic BioscienceDownload

          Conclusion

          Type III collagen pro-peptides (nordicPRO-C3™) is produced by activated lung CAFs and is a surrogate of fibrogenesis. High nordicPRO-C3™ levels in pre-treatment plasma associate with poor outcome for patients with NSCLC treated with anti-PD1 plus chemotherapy. These findings suggest that quantifying tumor fibrosis is important for prognostication of patients with lung cancer.

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            Obesity – A Key Driver in Osteoarthritis

            Posted on by Claire Hornung

            Introduction

            Obesity contributes to several comorbidities, including osteoarthritis (OA), which lowers quality of life due to joint pain and reduced function. Obesity worsens OA symptoms by increasing mechanical load and stress in addition to the elevated general inflammatory state. Moreover, this inflammatory drive is the prime suspect in the observed increased OA in non-weight-bearing joints of patients with obesity, such as the hands, suggesting systemic mechanisms are involved. Inflammatory mediators released by adipose tissue, including leptin, interleukin-6 (IL-6), and C-reactive protein (CRP), may contribute to heightened pain sensitivity and reduced pain thresholds in individuals with obesity.

            In this study we aimed to investigate the association between the painful experience and the body mass indices of patients at baseline in a previous phase III clinical trial. Furthermore, we evaluated the change in painful experience resulting from weight loss or gain after 2 years, as measured in the last follow-up of the clinical trial.

            Poster

            OARSI2025 Obesity in OA_Nordic BioscienceDownload

            Conclusion

            These studies indicate that increased body weight is associated with increased OA pain which is further confirmed by reduce patient-reported obesity-related OA pain upon undergoing weight loss.

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              Serum Immunoassays Identify CRTAC1 as A Biomarker of Osteoarthritis

              Posted on by Claire Hornung

              Serum immunoassays identify cartilage acidic protein (CRTAC1) as a biomarker of osteoarthritis

              Introduction

              Cartilage acidic protein 1 (CRTAC1), a glycosylated extracellular matrix protein, is primarily produced by chondrocytes in articular cartilage. Recent studies have indicated that circulating CRTAC1 levels are associated with the severity and progression of osteoarthritis (OA). However, CRTAC1 levels were measured using proteomic platforms, highlighting the need for easily quantifiable and reliable assays.

              Poster

              OARSI 2025 CRTAC1_Nordic BioscienceDownload

              Conclusion

              This study validated  CRTAC1 as a promising new biomarker for OA, utilizing easily quantifiable serum immunoassays. Differences in diagnostic performance between the total and neo-epitope CRTAC1 assays were observed. In conclusion, this study offers valuable insights into the role of CRTAC1 and its degradation process in Osteoarthritis.

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                World Parkinson’s Day: Biomarkers in Parkinson’s Disease

                Posted on by Claire Hornung

                April 11th marks World Parkinson’s Day, which aims to spread awareness for the millions of patients with Parkinson’s.

                Parkinson’s is the fastest growing neurological disease and there currently is no cure. One of the main challenges in developing effective treatments for Parkinson’s disease is the need to diagnose patients early, identify those with rapid disease progression, and monitor treatment response through reliable indicators.

                Nordic Bioscience has developed a blood-based biomarker targeting a pathological fragment of alpha-synuclein cleaved by Calpain-1, which aggregates into fibrils as part of the disease process. This biomarker has been shown to be upregulated in patients with Parkinson’s disease. Since this pathological fragment is generated before fibril aggregation occurs, we can identify patients early.

                In our paper published in Scientific Reports, we describe the development and potential of this biomarker in two clinical cohorts of patients with Parkinson’s Disease.

                Monitoring Therapeutic Responses in Systemic Sclerosis (SSc)

                Posted on by Claire Hornung

                It can be a cumbersome clinical challenge to monitor subtle changes in collagen turnover in Systemic Sclerosis (SSc), a complex autoimmune condition marked by skin and organ fibrosis.

                We are excited to share our latest open access paper in Arthritis Research & Therapy, produced in collaboration with Dr. Satoshi Kubo. Our study reveals that although type VII collagen—an essential anchoring fibril in the skin’s basement membrane—is not directly linked to skin stiffness, its turnover is significantly elevated in SSc, even when disease activity appears low.

                In this study, we have shown that the dynamics of type VII collagen remodeling can be quantified using the serological biomarker PRO-C7, measuring type VII collagen formation, and it’s counterpart measuring collagen degradation, C7M. By tracking these biomarkers, clinicians can identify patients with hidden yet active collagen turnover, allowing for more personalized treatment strategies and better monitoring of therapeutic responses.

                Article: Accelerated Type VII collagen turnover in systemic sclerosis patients, reflected by serological neo-epitope fragment biomarkers

                Developing a Blood-Based Biomarker for the Early Diagnosis of PD

                Posted on by Claire Hornung

                Developing a blood-based biomarker targeting α-synuclein fragments for the early diagnosis of PD

                Introduction

                Parkinson’s disease (PD) affects millions worldwide and currently has no cure. Treatments focus only on managing symptoms, explaining why there is a pressing need for biomarkers and advanced diagnostic tools to enable earlier detection and better disease management. In the early stages of PD, α-synuclein—can be cleaved by Calpain I, presenting a potential target for biomarker development.

                The aim of this study was to develop a sensitive immunoassay that detects α-synuclein fragments.

                Poster

                ADPD2025 alpha-synuclein in PD_Nordic BioscienceDownload

                Conclusion

                α-Synuclein fragments cleaved by calpain I are key early drivers of Parkinson’s disease pathology. This blood-based biomarker holds promise for enabling early diagnosis and identifying patients who are likely to respond to treatment.

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