Nordic Bioscience has announced that its CPa9-HNE biomarker assay has received a Letter of Support (LoS) from the U.S. Food and Drug Administration (FDA). This biomarker is designed to identify neutrophil activation in patients with inflammatory bowel disease (IBD) by measuring a fragment of calprotectin S100a9.
Significance of CPa9-HNE in IBD Management
IBD, encompassing conditions like ulcerative colitis and Crohn's disease, affects millions worldwide. Neutrophils, key immune cells, play a significant role in the pathogenesis of IBD. The CPa9-HNE biomarker offers a non-invasive method to quantify activated neutrophils in the serum and plasma of IBD patients, providing a potential indicator of disease activity.
Potential Applications in 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 applied as a patient enrichment tool for clinical trials. By identifying patients more likely to have moderate or severe endoscopic disease activity, CPa9-HNE can significantly streamline patient recruitment, ensuring the right patient profiles are targeted.
Monitoring Disease Activity and Treatment Response
CPa9-HNE, as a serum calprotectin biomarker, provides a blood-based measure of disease activity. This feature holds promise for monitoring disease activity and treatment response in IBD patients, offering a more accessible and less invasive alternative to traditional methods.
Nordic Bioscience's Expertise in Biomarker Technology
Nordic Bioscience has a history in ECM remodeling research, with previous 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 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 trifecta of scientific excellence, high-quality biomarkers, and regulatory support.
