Nordic Bioscience has announced that the U.S. Food and Drug Administration (FDA) has issued a Letter of Support (LoS) for its CPa9-HNE biomarker assay. This assay is designed to measure a fragment of calprotectin S100a9, which is produced by human neutrophil elastase and found in the serum and plasma of individuals with inflammatory bowel disease (IBD).
The CPa9-HNE biomarker quantifies activated neutrophils, offering a non-invasive method to assess disease activity in patients with IBD. The biomarker may help to identify patients with moderate to severe ulcerative colitis or Crohn’s disease, who are often the target population in IBD clinical trials.
Potential Impact on Clinical Trials
According to Joachim Høg Mortensen, Scientific Director of Gastrointestinal Diseases at Nordic Bioscience, the Letter of Support underscores the potential of CPa9-HNE to be used as a patient enrichment tool for future clinical trials. "This marker has the potential to be applied as a patient enriching tool for clinical trials in the future, by identifying patients more likely to have moderate or severe endoscopic disease activity," Mortensen stated. This approach could significantly streamline patient recruitment by ensuring that trials target the appropriate patient profiles.
Monitoring Disease Activity
In addition to patient enrichment, CPa9-HNE, as a serum calprotectin biomarker, provides a blood-based measure of disease activity. This feature has the potential to be used for monitoring disease activity and treatment response in IBD patients, offering a less invasive alternative to current methods.
Nordic Bioscience's Biomarker Technology
Nordic Bioscience has a history in ECM remodeling research, previously earning FDA Letters of Support for its PRO-C3 and PRO-C6 biomarkers. The company has also transferred the FDA-approved bone biomarker CTX-I and fibrogenesis biomarker PRO-C3 to the Roche COBAS platform. With a portfolio of over 125 ELISA biomarkers developed to quantify unique ECM fragments, Nordic Bioscience's tools are utilized across various stages of drug development and patient selection in multiple diseases.
Executive Perspective
Morten A. Karsdal, CEO of Nordic Bioscience, commented on the achievement, stating, "This trifecta of scientific excellence, high-quality biomarkers, and regulatory support sets us apart from the competition. 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."
