The FIB-NIT™ Biomarker Panel

The FIB-NIT™ Biomarker Panel provides a non-invasive assessment of fibrosis by measuring key ECM biomarkers—NordicPRO-C3®, NordicPRO-C6™, and NordicCTX-III™. It helps track fibrogenesis, fibrolysis, and disease progression, supporting patient selection and treatment monitoring in clinical trials.

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FIB-NIT™—your companion in fibrosis research

FIB-NIT™ (Fibrosis Non-Invasive Tests) is an innovative panel that utilizes biomarkers of fibrotic processes.

These biomarkers have been proven to associate with superior pharmacodynamic and supportive prognostic performance to investigate dynamics within fibrotic diseases, including understanding drug efficacy in such indications —demonstrated in over 100 publications in relevant and peer-reviewed scientific journals.

The FIB-NIT™ panel consists of the fibrogenesis nordicPRO-C3™, the fibrolysis nordicCTX-III™, and the outcome risk nordicPRO-C6™ biomarkers.

Biomarkers in the FIB-NIT™ panel

ECM biomarkers and FIB-NIT™

Biomarkers of the ECM, especially those based on collagens, are efficient tools to investigate fibrotic processes. Collagens are major components of ECM that are affected by fibrosis in the injured tissue, which produce unique fragments. These unique fragments, called neo-epitopes, are released in the bloodstream where they can be non-invasively measured by the Nordic ProteinFingerPrint Biomarker Technology™ to understand ECM turnover disruption.

NordicPRO-C3™ (PRO-C3) and NordicPRO-C6™ (PRO-C6) are both associated with fibrogenesis and excessive production of ECM, while the biomarker NordicCTX-III™ (CTX-III) is related to fibrolysis and degradation of fibrotic tissue.

The FIB-NIT™ panel includes three of the most prominent Nordic Bioscience developed biomarkers to understand fibrogenesis, fibrolysis and risk of outcome. When combined, these three biomarkers provide a unique solution to monitor the mass balance of ECM remodeling as well as fibrosis dynamics which can contribute to accelerated clinical trials.

FIB-NIT™ achieves this by helping with patient selection and inclusion, identification of treatment responders, assessment and prediction of drug response without the need for invasive procedures like biopsy; or the use of expensive noninvasive screening tests that are commonly used in the clinical practice.

NordicPRO-C3™, a true marker of fibrogenesis

NordicPRO-C3™ (ADAMTS2 mediated release of the N-terminal pro-peptide of type III collagen) measures the formation of type III collagen which has been shown to be a key process behind fibrogenesis development and progression in different organs and tissues (liver, lung, kidney, heart, intestines, skin). Concentrations of PRO-C3 give an estimation of the level of active fibrogenesis and can be useful as a clinical research tool to identify patients at risk to develop outcomes and predict the incidence of liver related events.

PRO-C3, being a neoepitope differs from PIIINP, as the former is formation specific, while the latter measures both formation and degradation of type III collagen, yielding a less precise measurement.

Figure 1[1]. PRO-C3 levels allow to stratify patients with advanced liver fibrosis (F4) with a higher degree of active fibrogenesis and, consequently, at a higher risk to develop outcomes.

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Table 1. PRO-C3 levels dynamically change upon anti-fibrotic treatment with Efruxifermin allowing to monitor drug response and pharmacodynamics in phase 2 MASH intervention studies.
Table 2. PRO-C3 levels allow to monitor drug response and pharmacodynamics in phase 2 and 3 metabolic intervention studies with focus in MASH and obesity.
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NordicPRO-C6™, a marker of outcome

NordicPRO-C6™ (C-terminal of type VI collagen α3 chain; also known as Endotrophin) measures the formation of type VI collagen and the signaling molecule Endotrophin which correlates to fibrogenesis, fibroblast activity and, to metabolic processes.

PRO-C6 acts as a driver of fibro-inflammatory processes, providing an efficient tool to predict outcomes (risk of cardiovascular events, HFpEF pathology; mortality; disease progression) in many different fibrotic diseases affecting liver, heart, kidneys, and the gastrointestinal system.

Endotrophin has a major role for the development and progression of metabolic disorders and is highly correlated to a pro-fibrotic, pro-inflammatory and angiogenesis endotype, allowing to identify patients with preserved ejection fraction (HFpEF) that are at risk of developing cardiovascular events and at risk of death.

Endotrophin measured through nordicPRO-C6™ levels has shown prognostic potential for predicting mortality in many different pathological conditions such as liver, cardiovascular, metabolic, respiratory, kidney diseases, diabetes and cancer.

 

 

Figure 2. PRO-C6 as a marker of type VI collagen formation and Endotrophin signaling activity.
Figure 3[2]. PRO-C6 levels indicate abnormal metabolic activity and can be used for identification of patients with cardiovascular (CV) diseases at risk of heart failure and death related to cardiovascular events. PRO-C6 outperforms standard biomarkers and scores used in the clinic for prognosis of cardiovascular diseases. Primary endpoint: CV death from CV causes, aborted cardiac arrest or hospitalization for HF. Data adjusted for age, gender, race, diabetes, history of MI & glomerular filtration rate (GFR).

NordicCTX-III™, a marker of fibrosis resolution and endotyping

NordicCTX-III™, (fragment of MMP degraded crosslinked type III collagen) measures the proteolytic degradation of cross-linked type III collagen, a process which indicates fibrolysis and fibrosis resolution. Interventions based on drug treatment and lifestyle changes can stimulate the production of proteolytic enzymes that cleave ECM excess, especially type III collagen, in fibrotic conditions, leading to improvement of fibrosis via resolution.

By measuring CTX-III, we may assess patients who have progressive, stable or regressive fibrosis. MASLD patients with higher concentrations of CTX-III have higher rates of fibrolysis and are more likely to present a more regressive endotype of fibrosis following interventions focused on improving liver health, for example, weight loss due to bariatric surgery.

Figure 4[3]. CTX-III separates regressors from stable and progressor patients.

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FIB-NIT™

  • The FIB-NIT™ panel is a non-invasive diagnostic and research tool that measures three key ECM biomarkers—NordicPRO-C3™, NordicPRO-C6™, and NordicCTX-III™—to assess fibrogenesis, fibrolysis, and fibrosis progression. It supports patient selection, treatment monitoring, and outcome prediction in clinical trials across various fibrotic diseases.

  • FIB-NIT™ enhances fibrosis research by enabling early identification of fast-progressing patients, detecting treatment responses sooner than traditional methods like biopsies or imaging, and offering insights into drug efficacy through dynamic ECM remodeling measurement.

  • The biomarkers in the FIB-NIT™ panel are applicable across multiple fibrotic conditions, including liver disease (MASH/MASLD), heart failure (especially HFpEF), chronic kidney disease, pulmonary fibrosis, and metabolic and inflammatory disorders.

  • NordicPRO-C3™ specifically measures the formation of type III collagen, a key process in fibrogenesis, providing a more precise assessment of active fibrosis compared to traditional markers like PIIINP, which do not distinguish between formation and degradation.

  • NordicPRO-C6™ reflects type VI collagen formation and Endotrophin activity, offering prognostic insights into outcomes like cardiovascular events and mortality. NordicCTX-III™, on the other hand, indicates fibrolysis, helping identify patients with regressive fibrosis who may respond well to treatment or lifestyle changes.

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