{"id":2336,"date":"2025-02-01T21:59:27","date_gmt":"2025-02-01T21:59:27","guid":{"rendered":"https:\/\/www.nordicbioscience.com\/?page_id=2336"},"modified":"2025-06-03T07:49:56","modified_gmt":"2025-06-03T07:49:56","slug":"cpa9-hne-nordiccpa9-hne-the-serum-calprotectin","status":"publish","type":"page","link":"https:\/\/www.nordicbioscience.com\/technology\/cpa9-hne-nordiccpa9-hne-the-serum-calprotectin\/","title":{"rendered":"CPa9-HNE (NordicCPa9-HNE\u2122)\u2014The Serum Calprotectin"},"content":{"rendered":"
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CPa9-HNE (NordicCPa9-HNE\u2122)\u2014The Serum Calprotectin<\/h1>\n

CPa9-HNE\u2122 is the serum calprotectin biomarker that measures true neutrophil activity by detecting a specific calprotectin fragment. Unlike full-length calprotectin, CPa9-HNE is released only during active inflammation, making it a valuable tool for assessing immune response and monitoring treatment effects in conditions like IBD. Supported by an FDA Letter of Support, it has potential for improving clinical trials by enabling non-invasive assessment of disease activity.<\/p>\n

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CPa9-HNE\u2014A measure of true neutrophil activity<\/h2>\n \n\n <\/div>\n
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The\u00a0CPa9-HNE (nordicCPa9-HNE\u2122) biomarker\u00a0provides a measure of\u00a0true neutrophil activity<\/b>\u00a0by capturing the interplay between two specific key neutrophilic intracellular components; the antimicrobial protein\u00a0calprotectin<\/b>\u00a0and the protease\u00a0human neutrophil elastase\u00a0<\/b>(HNE).<\/p>\n

Constant activation and recruitment of neutrophils\u00a0<\/b>is a common feature in IBD (Crohn\u2019s disease and ulcerative colitis). Their infiltration into the intestinal tissue has been\u00a0correlated to disease activity<\/b>, where they induce mucosal damage through the release of neutrophil extracellular traps (NETosis).\u00a0Therefore, measuring\u00a0neutrophil activity using CPa9-HNE<\/b>\u00a0provides valuable insight into disease progression and inflammatory burden, potentially guiding the development and evaluation of novel therapeutic interventions, as further encouraged by the\u00a0Letter of Support\u00a0<\/b>from the FDA<\/a>.<\/p>\n <\/div>\n <\/div>\n <\/article>\n

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Generation of the CPa9-HNE neo-epitope<\/h2>\n \n\n <\/div>\n
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Neutrophils travel toward the site of inflammation by migrating across the endothelium.<\/p>\n

Upon reaching the site of injury, neutrophils activate and undergo NETosis, releasing their intracellular components such as human neutrophil elastase (HNE) and CP.<\/p>\n

This leads to the generation of the CPa9-HNE neo-epitope in the extracellular space. Subsequently, upon tissue clearance, the fragment gets released into circulation, serving as a measure of neutrophil activity.<\/p>\n <\/div>\n <\/div>\n

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CPa9-HNE is a pharmacodynamic biomarker<\/h2>\n \n\n <\/div>\n
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The CPa9-HNE assay measures a specific calprotectin fragment, CPa9-HNE, that serves as a biomarker for activated neutrophils. While full-length calprotectin can be passively released by resting or inactive neutrophils, CPa9-HNE is released exclusively when neutrophils become activated, often in response to infection or inflammation. This specificity allows the assay to distinguish between baseline neutrophil presence and active inflammatory processes, making it a valuable tool for detecting active inflammation and monitoring immune response.<\/p>\n

CPa9-HNE provides added clinical value over measuring the full-length calprotectin protein alone. In patients achieving remission with the anti-TNF therapy adalimumab, levels of CPa9-HNE show a continuous reduction from baseline through week 52, reflecting a sustained decrease in neutrophil activation. This reduction serves as a marker of effective therapeutic response, offering insight into both the extent and duration of inflammation control in patients undergoing treatment.<\/p>\n <\/div>\n <\/div>\n

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The FDA acknowledges of CPa9-HNE as a potential enrichment biomarker<\/h2>\n \n\n <\/div>\n
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The CPa9-HNE<\/a> biomarker provides a measure of true neutrophil activity by capturing the interplay between two specific key neutrophilic intracellular components; the antimicrobial protein calprotectin and the protease human neutrophil elastase (HNE).<\/p>\n

The U.S. Food and Drug Administration (FDA) endorses the CPa9-HNE assay for further investigation as a tool for clinical trials, where it can support multiple objectives, such as clinical trial enrichment, assessing the pharmacodynamic effects of immunomodulatory drugs, and monitoring treatment response.<\/p>\n

For instance, CPa9-HNE strongly correlates with endoscopic disease activity. Furthermore, recent findings show that CPa9-HNE serves as an indicator for pharmacodynamic response, measuring the impact of the S1P modulator ozanimod on neutrophil activity \u2013 making it a valuable component for a comprehensive biomarker strategy, eventually improving patients\u2019 quality of life.<\/p>\n <\/div>\n <\/div>\n

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CPa9-HNE\u2014The Serum Calprotectin Technology<\/h2>\n\n\n\n

Unsure about how CPa9-HNE can change clinical trials in IBD? Watch this short video and get an understanding of how the CPa9-HNE biomarker assesses true neutrophil activity in IBD, Crohn\u2019s disease, ulcerative colitis, and other inflammatory diseases.<\/p>\n\n\n\n

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