Castle Creek Biosciences

Castle Creek Biosciences is a clinical-stage cell and gene therapy company founded in 2015 and headquartered in Exton, Pennsylvania. The company is advancing a pipeline of autologous, ex vivo gene therapies, with a lead program (D-Fi/FCX-007) in a registrational Phase 3 trial for dystrophic epidermolysis bullosa, a severe and debilitating genetic skin disorder. As a portfolio company of Paragon Biosciences, Castle Creek leverages a distinctive fibroblast-based technology platform aimed at localized treatment of monogenic diseases, positioning it as a specialized player in the regenerative medicine space for conditions with high unmet need.

Proprietary autologous fibroblast platform for ex vivo gene correction and localized, re-dosable intradermal delivery, initially targeting skin and connective tissue disorders.

Competition in DEB includes palliative care and a recently approved topical gel (Amryt Pharma's Filsuvez). Other gene therapy approaches, including CRISPR-based therapies (e.g., from Krystal Biotech) and in vivo viral vector therapies, are in development and could offer alternative, potentially more convenient treatment paradigms.