Author: Claire Hornung

Detecting ECM Turnover in AxSpA Patients with MRI Inflammation and Normal CRP

Posted on by Claire Hornung

Detecting Extracellular Matrix Turnover in axSpA Patients with concomitant Inflammation on MRI and Normal CRP

Introduction

Many patients with axial spondyloarthritis (axSpA) present normal CRP levels despite ongoing inflammation in the axial skeleton. The disease is characterized by hallmark features such as erosions and new bone formation, as well as aberrant neutrophil activation. We hypothesize that mechanistic biomarkers reflecting inflammation directly within the axial skeleton may provide a more accurate assessment of disease activity than CRP.

This study aims to investigate the association between the soluble biomarkers nordicCpa9-HNE™, C3M, and nordicPRO-C3™ and MRI-detected inflammation in the sacroiliac joint (SIJ) and spine of axSpA patients.

Poster

EULAR2024 ECM Turnover in axSpA_Nordic BioscienceDownload

Conclusion

NordicCPa9-HNE™, C3M, and CRP demonstrated significant correlations with spine MRI inflammation at baseline. Notably, CPa9-HNE and C3M exhibited superior sensitivity compared to CRP in detecting spine MRI inflammation at week 52. These findings suggest that nordicCPa9-HNE™ and C3M may serve as valuable biomarkers for monitoring disease activity changes in axial spondyloarthritis (AxSpA) with normal CRP.

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    NordicPRO-C3™ as a Predictor of Liver Related Outcomes in Chronic Hepatitis C

    Posted on by Claire Hornung

    PRO-C3 determined active fibrogenesis is a predictor of liver-related outcomes in patients with chronic hepatitis C

    Introduction

    Patients with untreated chronic hepatitis C (CHC) infection are at increased risk of developing a liver related outcome. Despite the availability of simplified direct-acting antiviral therapy, the prevalence of CHC remains unchanged in many industrialized countries. Biomarkers that can predict which chronic liver disease patients with inflammatory injury are at greatest risk of developing a clinical outcome are required. In this study we aim to investigate the ability of nordicPRO-C3™ as a marker of active fibrogenesis to predict liver-related outcomes compared to METAVIR fibrosis stage on biopsy in patients with hepatitis C.

    Poster

    EASL2024_Active_Fibrogenesis_Nordic BioscienceDownload

    Conclusion

    We conclude that fibrosis activity (nordicPRO-C3™) is associated with an increased risk of developing a liver-related outcome in patients with untreated HCV infection. NordicPRO-C3™ provides a higher risk predictor for outcomes than METAVIR fibrosis stage on biopsy. A pro-fibrogenic marker such as nordicPRO-C3™ could provide prognostic utility in other chronic liver disease patients with ongoing inflammatory injury.

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      NordicPRO-C6™ Is Prognostic for Liver-Related Events in CHC Patients with Cirrhosis

      Posted on by Claire Hornung

      Fibroblast activity kills – Circulating endotrophin (PRO-C6) is prognostic for liver-related events in patients with cirrhosis from chronic hepatitis C

      Introduction

      Prognostic markers for patients with compensated cirrhosis at increased risk of developing liver-related events are required. Endotrophin, a potential driver of fibroblast activation and mediator of fibroinflammatory disease, may be assessed non-invasively using nordicPRO-C6™. Blood-based collagen extracellular matrix remodeling markers may provide novel prognostic information to identify patients with cirrhosis at higher risk of developing a liver-related event.

      In this study we aimed to investigate the ability of nordicPRO-C6™ to predict liver-related events in The Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis Trial (HALT-C) (ClinicalTrials.gov #NCT00006164).

      Poster

      EASl2024 HALT-C PRO-C6_Nordic BioscienceDownload

      Conclusion

      NordicPRO-C6™, a biomarker of circulating endotrophin, was primarily associated with an increased risk of developing a liver-related event in patients with cirrhosis from CHC. NordicPRO-C6™ is a potential monitoring blood-based marker that may also provide prognostic information in treatment-naïve CHC patients with moderate-advanced fibrosis at higher risk of developing a liver-related event. The prognostic utility of nordicPRO-C6™ in CHC patients after sustained virologic response and other advanced stage chronic liver disease is required.

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        Endotrophin as an Early Marker of Kidney Outcomes in Type 2 Diabetes

        Posted on by Claire Hornung

        Endotrophin as an early marker of kidney outcomes in persons with type 2 diabetes: Findings from the PROVALID study

        Introduction

        Diabetic kidney disease (DKD) is driven by pathophysiological processes, including fibrosis. NordicEndotrophin™ (ETP), a pro-fibrotic fragment generated during collagen type VI formation, has previously been shown to be a biomarker of DKD progression1,2,3,4,5. The aim of this study was to investigate, for the first time, circulating ETP as a risk marker for kidney outcomes in persons with type 2 diabetes (T2D) being taken care of at the primary level of healthcare.

        Poster

        ERA2024 Endotrophin in Type 2 Diabetes_Nordic BioscienceDownload

        Conclusion

        Plasma ETP (nordicEndotrophin™) has been identified as an independent risk marker for kidney outcomes in individuals with type 2 diabetes (T2D) with early-stage kidney disease. Higher levels of ETP were associated with a significantly increased risk of developing the kidney endpoint in persons with eGFR >90 ml/min/1.73 m2. These findings demonstrate that markers of fibrosis, such as ETP, may serve as early markers for kidney disease progression or kidney failure in persons with T2D and apparently normal kidney function.

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          LG1M Is Prognostic for Long-Term Readmission After AKI

          Posted on by Claire Hornung

          The novel fibrosis biomarker LG1M is prognostic for long-term readmission after AKI

          Introduction

          Acute Kidney Injury (AKI), survivors are at increased risk of long-term adverse outcomes, including readmission to hospital. Pathophysiological consequences of AKI, include extracellular matrix (ECM) remodeling. Tools to monitor the long-term health risk of patients after AKI are needed to improve
          patient outcome.

          Poster

          ERA2024 LG1M in AKI_Nordic BioscienceDownload

          Conclusion

          Circulating levels of LG1M were elevated in AKI patients 1 year after the AKI episode and correlated with markers of kidney function in the AKI group and to a lower extent in the CKD control group. In the AKI group, LG1M was associated with the risk of readmission, even though the significance of the association was lost in adjusted analyses. This biomarker, quantifying circulating levels of a laminin fragment, may reflect injury to the basement membrane (of which laminin is a major component) after AKI, which was associated with an increased risk of worse outcome in patients that experienced an episode of AKI.

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            Advancing Diagnostic Precision of Emphysema COPD

            Posted on by Claire Hornung

            Machine-learning classification integrating non-invasive biomarkers, clinical characteristics and pulmonary function

            Introduction

            Computed tomography (CT) is used for evaluating phenotypic abnormalities in chronic obstructive
            pulmonary disease (COPD), yet its cost and time-intensive nature limit routine use. Developing an
            easily implementable technique for classifying emphysema extent is thus essential.

            This study aimed to develop a diagnostic model to classify emphysema extent in COPD
            patients relying solely on easily obtained measures such as clinical characteristics and
            non-invasive biomarkers.

            Poster

            ATS2024_Emphysema_Model Nordic BioscienceDownload

            Conclusion

            Diagnostic models incorporating easily obtainable measures effectively distinguished COPD patients with high emphysema extent from those with low extent. Such models for classifying emphysema patterns have the potential for clinical implementation, aiding in diagnosis or serving as a decision-making tool to determine the necessity of further CT scans.

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              Data-Driven Comorbidity Profiles in COPD

              Posted on by Claire Hornung

              Data-driven identification and investigation of comorbidity profiles in patients with chronic obstructive pulmonary disease: a multicohort study

              Introduction

              Comorbidities are common in chronic obstructive pulmonary disease (COPD), adversely affecting
              patients’ quality of life and their disease trajectories. While previous studies have predominantly
              examined individual comorbidities, there has been limited exploration of their coexistence.

              This study aimed to identify comorbidity clusters among real-world cohorts of COPD patients using machine learning techniques, and to investigate clinical characteristics and mortality within these clusters.

              Poster

              ATS2024_ Comorbidity_Clusters_Nordic BioscienceDownload

              Conclusion

              This study confirms distinct comorbidity clusters in two well-characterized cohorts of patients with COPD which can be linked to different patient subgroups. In a broad COPD patient population, comorbidity profiles could hold prognostic relevance. The findings of this study enhance the understanding of the comorbidity landscape in COPD and highlights the importance of comorbidity assessment in clinical management.

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                PRO-C11 and PRO-C16 Are Markers of Intestinal Fibrosis – Results from the ImageKids Study

                Posted on by Claire Hornung

                PRO-C11 and PRO-C16 are markers of intestinal fibrosis and are associated with MRE-confirmed intestinal strictures – Results from the ImageKids study

                Introduction

                Intestinal fibrosis and strictures is one of the most challenging complications in patients with
                Crohn’s disease (CD). There is an urgent medical need for non-invasive serological biomarkers for intestinal fibrosis, as magnetic resonance enterography (MRE) is not a feasible tool for repeated
                monitoring.

                In this study we investigated Protein FingerprintAssays (PFA) biomarkers of collagen formation,
                PRO-C11 (formation of type XI collagen), and PRO-C16 (formation of type XVI collagen) in serum from pediatric CD (pCD).

                Poster

                DDW2024_Imagekids study_Nordic Bioscience Download

                Conclusion

                Based on these biomarker data from the ImageKids study, PRO-C11 and PRO-C16 demonstrate potential as important non-invasive biomarkers reflecting intestinal fibrosis and stenosis.

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                  CPa9-HNE Can Monitor Endoscopic and Clinical Disease Activity in Ulcerative Colitis

                  Posted on by Claire Hornung

                  CPa9-HNE: A neutrophil-derived fragment of calprotectin measured in serum can monitor endoscopic and clinical disease activity in ulcerative colitis

                  Introduction

                  Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) presenting in remitting ulcerations of the colonic mucosa and submucosa. Mucosal healing is therefore an important treatment target for optimal disease management. Fecal calprotectin is commonly used to monitor mucosal healing –
                  however, patient compliance is low due to a preference for serological markers.

                  In this study we aimed to investigate the association of serum calprotectin [CPa9-HNE], a non-invasive neo-epitope biomarker of true neutrophil activity, with both clinical and endoscopic disease activity in UC.

                  Poster

                  DDW2024 CPa9-HNE in UC_Nordic BioscienceDownload

                  Conclusion

                  CPa9-HNE accurately reflected both clinical and endoscopic disease activity in ulcerative colitis, based on the UCEIS and full Mayo score. These findings highlight the potential use of CPa9-HNE as a non-invasive tool to monitor both endoscopic and clinical disease activity in UC, with the potential of guiding treatment decisions and better aligning with patient preferences.

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                    Fibrosis as a Driver of Cancer, Liver, and Heart-related Outcomes

                    Posted on by Claire Hornung

                    Join us for an insightful webinar, where experts will shed light on the multifaceted role of fibrosis in various health conditions.

                    This webinar offers a unique opportunity to gain comprehensive insights into the role of fibrosis in driving outcomes across various health conditions with a common component, providing valuable knowledge for researchers, clinicians, and healthcare professionals alike.

                    Agenda

                    • Fibroblast Activity Kills: The Basics of Extracellular Matrix in Health and Disease in Predicting Outcomes – Dr. Morten A. Karsdal
                    • The Extracellular Matrix of Cancers and The Modulation of the ECM – Dr. Raghu Kalluri
                    • Collagen biomarkers of Liver, Heart, and HCC Outcome – Dr. Diana Julie Leeming
                    • Q&A Break
                    • Liver Fibrosis and HCC –  Cause or Consequence?  – Dr. Scott Friedman
                    • Questions from the chat​​​​​​​

                    Overview and speakers

                    Our presentations will cover a wide array of topics, starting with an exploration of the fundamentals of the extracellular matrix in health and disease, emphasizing the impact of fibroblast activity on outcomes. The complex relationship between liver fibrosis and hepatocellular carcinoma (HCC) will be explored, examining whether fibrosis is a cause or consequence of this condition.

                    Further discussions will delve into the extracellular matrix of cancers and the modulation of the ECM, providing insights into the interplay between fibrosis and cancer outcomes. Lastly, we’ll explore collagen biomarkers and their role in predicting outcomes related to liver, heart, and HCC.

                    Watch replay

                    Dr. Scott L. Friedman

                    • Dr. Scott L. Friedman is the Dean for Therapeutic Discovery and Chief of the Division of Liver Diseases at the Icahn School of Medicine at Mount Sinai. He is renowned for his pioneering research into the underlying causes of scarring, or fibrosis, associated with chronic liver disease, which affects millions worldwide.
                    • Dr. Friedman was among the first to isolate and characterize the hepatic stellate cell, the key cell type responsible for scar production in the liver, leading to significant advancements in the field.
                    • His groundbreaking work has led to the development of new anti-fibrotic therapies for liver disease that are currently reaching clinical trials, contributing to the translation of basic science into clinically meaningful advances. Dr. Friedman’s research has been continuously funded by the NIH since 1985, and he received his first faculty NIH grant (RO1) in 1986 at the age of 31.
                    • He has authored over 300 peer-reviewed publications and has been recognized with numerous awards, including the International Hans Popper Award in 2003 for his outstanding contributions to the understanding and treatment of liver disease.
                    • Dr. Friedman’s leadership as Chief of the Division of Liver Diseases at Mount Sinai has led to significant expansion, including increasing the faculty from 5 to 25 individuals and overseeing the creation of the largest liver fellowship in the United States.
                    • He is a fellow of multiple prestigious medical societies, including the American Gastroenterological Association, the American College of Physicians, and the American Association for the Study of Liver Diseases, among others.

                    Dr. Raghu Kalluri

                    • Dr. Kalluri is a medical researcher focused on the cellular microenvironment and exosomes in health and disease.
                      He has mentored over 200 research trainees and led numerous education and training initiatives at Harvard and MD Anderson Cancer Center.
                    • He is co-Director of the MSTP, Assistant Dean of the graduate school, and Director of the Office of Mentoring and Training of Scientists at MD Anderson Cancer Center. His research has focused on extracellular matrix (ECM) biology, specifically basement membrane biology, and the discovery of several new ECM-derived endogenous angiogenesis inhibitors.
                    • He has contributed to our understanding of the role of TGF-β and BMP-induced epithelial to mesenchymal transition and mesenchymal to epithelial transition in organ fibrosis and cancer progression. His research has led to the identification of new therapeutic targets to combat organ fibrosis and the subsequent expansion of research on the cellular microenvironment to solid tumors, specifically pancreatic cancer.
                    • His research group has published over 350 papers in peer-reviewed journals, and his work has been translated into three successful Phase I clinical trials for cancer and the launch of five biotechnology companies.

                    Dr. Morten A. Karsdal

                    • Dr. Karsdal chairs the Extracellular Matrix Pharmacology Congress, an influential forum dedicated to advancing drug development by identifying changes in the ECM as common denominators in chronic diseases.
                    • Dr. Morten Karsdal joined Nordic Bioscience in 2001 and has been serving as CEO since June 2010.
                    • He is a prolific author, with more than 650 peer-reviewed articles to his name, accumulating over 34,000 citations and an h-index of 95.
                    • He is renowned for his expertise and commitment to biomarker development, extracellular matrix biology, and disease research, particularly in fibrosis, rheumatology, and diabetes. He possesses extensive experience in clinical trial design and the clinical application of biochemical markers, consulting for major pharmaceutical companies.
                    • As an honorary professor of inflammation research at the University of Southern Denmark, Dr. Karsdal supervises PhD students and contributes to advancing scientific knowledge in the field.
                    • In 2016, he authored the first edition of “Biochemistry of Collagens, Laminins and Elastin,” published by Elsevier Science, which is now in its 3rd edition, providing a comprehensive overview of structural proteins and their relevance in chronic diseases.
                    • Dr. Karsdal’s leadership and contributions to the Nordic Life Science community were recognized with the Arthur D. Little Nordic Life Science Award in 2023, highlighting his outstanding management and leadership achievements.

                    Dr. Diana Julie Leeming

                    • Dr. Diana Julie Leeming is the Senior Director of Fibrosis, Hepatic, and Pulmonary Research at Nordic Bioscience.
                      She joined Nordic Bioscience in 2004 and assumed the role of Director of Fibrosis in 2010, later being promoted to Senior Director in 2024.
                    • Diana leads a team of 20 scientists and technicians dedicated to the development and clinical application of extracellular matrix (ECM) biomarkers in hepatic and pulmonary diseases with a fibrotic component. Her role involves overseeing the development of novel ECM biomarkers and implementing them in preclinical drug testing and clinical trials.
                    • Dr. Leeming focuses on developing serologically assessed markers to evaluate extracellular matrix remodeling in patients with pulmonary or hepatic fibrosis, aiding in diagnosis and pharmacodynamic evaluation.
                    • She is a principal inventor of the PRO-C3 assay, a fibrogenesis marker utilized in multiple clinical trial studies.
                    • Dr. Leeming has authored over 180 peer-reviewed publications, demonstrating her extensive contributions to the field. Her H-index is 61, her I10-index is 174, and her research has garnered over 11,825 citations as of March 2024.

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