A drug development route for success is key but often challenging and full of uncertainties. Strategies that can increase the likelihood of success are vital. The FDA and EMA recognize that biomarker-based drug development strategies could be the solution in combination with translation research. This approach offers a biology-focused pathway that reduces time and cost and enhances the overall likelihood of success.
Our major cornerstone is combining translational models with clinically validated biomarkers to enhance drug development. For this purpose, we have assessed the ability of our biomarkers to bridge the gap between patients with dermatological disease and our various model systems. Our investigations have revealed that ProteinFingerPrint™ biomarkers, such as the nordicPRO-C3™ (PRO-C3) and nordicC3M™ (C3M), reflecting tissue formation and destruction, can assess dermal tissue turnover. We have assessed the biomarkers in the supernatants from our in-vitro models, the blood from in-vivo models, and the blood of patients with Dermatological pathologies (figure 1). These findings underline the translational and pharmacodynamic use of the Nordic ProteinFingerPrint Technology™.
Figure 1. Nordic Bioscience biomarkers in in-vitro, in-vivo models and in the blood of patients
These findings underline the use of the Nordic ProteinFingerPrint TechnologyTM pharmacodynamically and translationally. Browse our biomarker portfolio of pulmonary biomarkers to guide your translational research!
Various in vivo models mimicking dermal pathologies, such as the skin bleomycin model, represent important translational tools to study dermal inflammation and fibrosis in vivo. By collecting blood from these animals, dermal tissue remodeling can be evaluated using the Nordic ProteinFingerPrint™ biomarkers to assess drug efficacy and pharmacodynamic effects in preparation for clinical trials. In a study using the skin bleomycin (Figure 2.) for the induction of dermal damage, the biomarker nordicC3M™ (C3M) was evaluated. A significant increase of type III collagen degradation was observed using bleomycin to induce dermal damage. |  Figure 2. Skin bleomycin with elevated C3M levels |
| The prolonged Scar-in-a-Jar is a novel model that employs macro-molecular crowding to promote extracellular matrix formation, maturation, and deposition in vitro (Figure 3). The extracellular matrix plays a crucial role in providing structural support to cells and regulating tissue repair and regeneration by acting as a reservoir for growth factors and cytokines. Understanding the extracellular matrix dynamics is vital for developing therapeutic strategies. Using macromolecular crowding, the model becomes more 3D-like and increases complexity, making it a suitable translational model. |
By stimulating patient-derived dermal fibroblasts with pro-fibrogenic and pro-inflammatory cytokines, we can model dermal fibrosis in vitro and evaluate the efficacy of direct anti-fibrotic treatment using the Nordic ProteinFingerPrint™ biomarkers. Thus, we can determine efficacy by measuring collagen formation in the supernatants, allowing direct translation to clinical settings.
For example, the anti-fibrotic effects of compounds, such as the JAK-STAT inhibitor Tofactinib (figure 4A+B), can be evaluated. Here, we demonstrated the anti-fibrotic effects of Tofacitinib inhibiting type III and VI collagen formation, showcasing the biomarkers applicability as efficacy biomarkers in the in-vitro setting.
Figure 4. Nordic Bioscience's biomarkers demonstrate fibrotic burden and anti-fibrotic effects of compounds
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