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Nordic Bioscience receives Letter of Support from the U.S. Food and Drug Administration (FDA) for further study of the CPa9-HNE biomarker assay in inflammatory bowel disease (IBD) studies

• The FDA supports further study of CPa9-HNE, a blood-based biomarker to measure neutrophil activity in patients with inflammatory bowel disease (IBD), aiming to provide a non-invasive assessment of endoscopic disease activity.
• CPa9-HNE may enhance clinical trials by identifying patients with moderate to severe active ulcerative colitis or Crohn’s disease, potentially reducing the need for unnecessary endoscopies.
• The FDA encourages formal qualification of CPa9-HNE as an enrichment biomarker through analytical validation and data sharing across clinical trials to advance its development as a drug development tool.

Herlev, Denmark, 7 October 2024 - Nordic Bioscience, a leading biomarker company, today announced that the Company’s CPa9-HNE biomarker assay (the Nordic Serum Calprotectin assay) has received a Letter of Support (LoS) from the U.S. Food and Drug Administration (FDA)^[1,2].

For the past thirty years, Nordic Bioscience has continuously advanced its biomarker technologies, driven by its scientific breakthroughs published in high-impact journals, ongoing enhancements to its high-precision automated instruments^[3], and consistent regulatory approvals from official authorities.

Letter of Support for CPa9-HNE in IBD

“This trifecta of scientific excellence, high quality biomarkers, and regulatory support is what sets us apart from the competition” commented Morten A. Karsdal, Chief Executive Officer of Nordic Bioscience. “The CPa9-HNE Letter of Support is not only another landmark achievement signifying our success story, but also something that our hard-working teams can be very proud of.”

The CPa9-HNE biomarker measures a fragment of calprotectin S100a9, produced through the breakdown of calprotectin by human neutrophil elastase. CPa9-HNE is detected in the serum and plasma of individuals with inflammatory bowel disease (IBD) and is designed to quantify activated neutrophils, offering a non-invasive and objective indicator of endoscopic disease activity. In IBD clinical trials, the most frequent target for drug evaluation is the treatment of patients with moderate to severe ulcerative colitis or Crohn's disease. Neutrophils are important immune cells contributing to disease activity in IBD, and a tool like CPa9-HNE can play a key role in improving disease activity monitoring.

CPa9-HNE identifies true neutrophil activated, measured in the blood

“The Letter of Supports underlines what we have sought to achieve with CPa9-HNE: by using this biomarker, we can enrich trial populations by identifying patients more likely to have moderate or severe endoscopic disease activity” added Joachim Høg Mortensen, Scientific Director of Gastrointestinal Diseases, Nordic Bioscience. “This can significantly streamline patient recruitment, ensuring you target the right profiles. In addition, CPa9-HNE, as a serum calprotectin biomarker, provides a blood-based measure of disease activity, and has the potential to be used for monitoring of disease activity and treatment response.”

Nordic Bioscience has a strong history in ECM remodeling research, earning FDA Letters of Support and Intent for its PRO-C3 and PRO-C6 biomarkers. The Company has successfully transferred the FDA-approved bone biomarker CTX-I and fibrogenesis biomarker PRO-C3 to the Roche COBAS platform. With over 125 ELISA biomarkers developed to quantify unique ECM fragments, Nordic Bioscience's tools are used in all stages of drug development and patient selection across various diseases. 

For more information please contact:

Nordic Bioscience A/S
Dr. Joachim Høg Mortensen
Tel: +45 4452 5252
Email: jhm@nordicbio.com

Nordic Bioscience A/S
Elijah Aighobahi
Tel: +45 4452 5252
Email: eai@nordicbio.com

[1] https://www.nordicbioscience.com/images/materials/CPa9-HNE_LOS_Nordic_Bioscience.pdf

[2]https://www.fda.gov/drugs/biomarker-qualification-program/letter-support-los-initiative

[3] CPa9-HNE is currently measured in hand-held ELISA assays, however, it is in development to be used on high precision automated platforms. Not for use in diagnostic procedures.