Author: Claire Hornung

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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                Single Joint Tissue Destruction Biomarkers

                Posted on by Claire Hornung

                Single joint tissue destruction biomarkers: association between type III collagen degradation and local tissue damage of a single joint

                Introduction

                The landscape of osteoarthritis (OA) research and therapeutic development has undergone significant transformation, shifting from a primarily structural focus to an emphasis on patient-reported outcomes (PROs). Pain, which primarily originates from the soft tissue of the joint, is intricately linked with the structural integrity of joint tissues. Serological biomarkers are considered potential surrogate endpoints, but their contribution from single joints to systemic levels in OA patients is unclear.

                This study explored systemic biomarker levels’ response to tissue damage and healing in patients undergoing knee or hip joint replacement revision for aseptic failure, compared to patients with chronic pain from a joint replacement, but not receiving surgery.

                Poster

                OARSI2024_C3M OA_Nordic BioscienceDownload

                Conclusion

                C3M degradation was found to increase in response to tissue insult to the joint from revision surgery, while no change was observed in a non-surgical group with chronic pain of the joint over 6 months. The increase and gradual decrease throughout the study period indicate a relationship between systemic levels of type III collagen degradation fragments and soft-tissue destruction and inflammation of the joint.

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                  Weight Loss Lead to Significant Effects on OA Pain and Function: Do the Benefits Outweigh the Risks?

                  Posted on by Claire Hornung

                  Introduction

                  Drug development in the osteoarthritis (OA) field has proven extremely difficult, with a discordance between joint structure and pain. Weight loss has been associated with an effect on pain and function. Several molecular endotypes have been suggested for OA, which could be treatable, such as bone, inflammation, and lately, an overweight endotype.

                  The aim was to investigate the relationship between obesity, weight loss and patient-reported outcomes (PROs) in patients with persistent pain, and the effect on joint and bone tissue related soluble biomarkers.

                  Poster

                  OARSI2024 Weight Loss in OA_Nordic BioscienceDownload

                  Conclusion

                  Changes in PROs were significantly associated with obesity. Weight loss was associated with an increase in bone and cartilage degradation, as well as lowering in the interstitial matrix degradation. These data indicate that weight loss comes with a risk of increased joint tissue loss, but improvement in tissue inflammation.

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                    Stakeholder Alignment Under the Clinical Trial Symposium (CTS) & OARSI Umbrella

                    Posted on by Claire Hornung

                    Regulatory enablement of molecular endotypes for drug development. Definition of the context of use (COU) and molecular endotype which most urgently will assist in drug development: Stakeholder alignment under the Clinical Trial Symposium (CTS) & OARSI umbrella

                    Introduction

                    For a biomarker to be considered in therapeutic development, it must navigate various approval pathways. In the US, acceptance for single therapeutic trials is via IND, NDA, and BLA submissions, while for multiple drug development programs, it’s through the Biomarker Qualification Program. This program specifically evaluates the biomarker itself, not the measurement method.

                    Alternatively, in the US, a biomarker test can be approved by CDRH, leading to a legally marketable In-Vitro Diagnostic (IVD). The De Novo classification offers a pathway for novel medical devices, based on risk classification. Additionally, the 510(k) submission demonstrates equivalence to predicate devices, while PMA evaluates Class III device safety and efficacy. In the EU, approval is through CE marking, aligning with US FDA pathways.

                    A biomarker for general drug development can be qualified by CDER through the Biomarker Qualification Program, resulting in a tool usable under specific COUs. This process involves collaborative efforts with regulatory agencies and stakeholders, often in consortia, to streamline qualification. Monitoring biomarkers play a pivotal role in medical product development, furnishing tangible evidence of treatment impact, while predictive biomarkers serve to mitigate trial risks and minimize failures by pinpointing responsive patient subgroups.

                    Poster

                    OARSI2024 Regulatory_Nordic BioscienceDownload

                    Conclusion

                    Defining the Context of Use (COU) within real-world or clinical study populations is essential for biomarker development. Following CLSI guidelines ensures technical robustness, while careful risk-benefit evaluation supports clinical relevance. The regulatory enablement of molecular endotypes is essential for drug development.

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