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 identify neutrophil activation through blood samples, offering a potential advancement in monitoring and managing inflammatory bowel disease (IBD).
CPa9-HNE: A Novel Biomarker for IBD
The CPa9-HNE biomarker measures a fragment of calprotectin S100a9, which is produced by human neutrophil elastase. Found in the serum and plasma of individuals with IBD, this biomarker quantifies activated neutrophils, providing a non-invasive indicator of disease activity. According to Joachim Høg Mortensen, Scientific Director of Gastrointestinal Diseases at Nordic Bioscience, CPa9-HNE has the potential to identify patients more likely to have moderate or severe endoscopic disease activity.
Streamlining Clinical Trials
The Letter of Support from the FDA highlights the potential of CPa9-HNE to be used as a patient enrichment tool for clinical trials. By identifying patients with more severe disease, CPa9-HNE can significantly streamline patient recruitment, ensuring that the right patient profiles are targeted. In IBD trials, a frequent drug evaluation target is treating patients with moderate to severe ulcerative colitis or Crohn's disease. Neutrophils are important immune cells contributing to IBD, and CPa9-HNE can improve disease activity monitoring.
Monitoring Disease Activity and Treatment Response
In addition to its role in patient selection, CPa9-HNE offers a blood-based measure of disease activity, making it a valuable tool for monitoring treatment response. This is particularly relevant in the context of IBD, where assessing disease activity often requires invasive procedures. The ability to monitor disease activity through a simple blood test could significantly improve patient care and treatment outcomes.
Nordic Bioscience's Expertise in Biomarker Technology
Nordic Bioscience has a strong history in ECM remodeling research, previously earning FDA Letters of Support for its PRO-C3 and PRO-C6 biomarkers. The Company has 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 across all stages of drug development and patient selection in various diseases. Morten A. Karsdal, CEO of Nordic Bioscience, emphasized the company's commitment to scientific excellence, high-quality biomarkers, and regulatory support.
