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 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 FDA's support signals a significant step forward in the development and application of this biomarker for clinical trials and disease monitoring in IBD.
Significance of CPa9-HNE in IBD Management
CPa9-HNE quantifies activated neutrophils, which are crucial immune cells contributing to IBD pathology. In clinical trials focused on IBD, particularly ulcerative colitis and Crohn's disease, evaluating drug efficacy often involves assessing the impact on neutrophil 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, thereby streamlining patient recruitment for clinical trials.
Potential Applications in Clinical Trials
The Letter of Support from the FDA underscores the potential of CPa9-HNE to serve as a patient enrichment tool. By identifying patients with specific disease activity profiles, clinical trials can be more targeted, ensuring that the right patients are enrolled. Furthermore, as a serum calprotectin biomarker, CPa9-HNE offers a blood-based measure of disease activity, which can be used for monitoring disease progression and treatment response. This non-invasive approach could significantly improve the efficiency and effectiveness of IBD clinical trials.
Nordic Bioscience's Expertise in Biomarker Technology
Nordic Bioscience has a long-standing history in ECM remodeling research and has previously received FDA Letters of Support for its PRO-C3 and PRO-C6 biomarkers. The company has also successfully transferred its FDA-approved bone biomarker CTX-I and fibrogenesis biomarker PRO-C3 to the Roche COBAS platform. With a portfolio of over 125 ELISA biomarkers designed to quantify unique ECM fragments, Nordic Bioscience's tools are utilized across various stages of drug development and patient selection in a wide range of diseases. Morten A. Karsdal, CEO of Nordic Bioscience, emphasized the company's commitment to scientific excellence, high-quality biomarkers, and regulatory support, highlighting the CPa9-HNE Letter of Support as a landmark achievement.
Future Development
While CPa9-HNE is currently measured using hand-held ELISA assays, Nordic Bioscience is actively developing high-precision automated platforms to enhance its accessibility and utility. This advancement will further solidify CPa9-HNE's role in improving patient outcomes and streamlining drug development in IBD.
