Castle Creek Pharmaceutical Holdings, Inc. completed the acquisition of Fibrocell Science, Inc. Both companies have advanced investigational therapies for the treatment of epidermolysis bullosa (EB) into late-stage clinical research.
Prior to the acquisition, Fibrocell initiated a pivotal Phase 3 clinical trial evaluating a gene therapy candidate, FCX-007, for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). The FDA has granted Regenerative Medicine Advanced Therapy (RMAT), Orphan Drug, Rare Pediatric Disease and Fast Track designations to FCX-007. Castle Creek has also continued Phase 2b clinical research evaluating a diacerein topical ointment, CCP-020, for epidermolysis bullosa simplex (EBS) and other forms of EB. The FDA has designated the CCP-020 program for Fast Track development in the treatment of EBS.
"Our organizations have a shared commitment to delivering new treatment options to underserved communities such as EB patients and their families who have no approved therapies," says Greg Wujek, chief executive officer of Castle Creek, in a news release. "The addition of this late-stage gene therapy will allow us to be the leader in rare genetic dermatology and additional genetic diseases as well."
Castle Creek is a portfolio company of Paragon Biosciences, which founded Castle Creek with the vision to deliver transformative therapies to patients with rare genetic dermatologic diseases. Fibrocell is a cell and gene therapy company focused on improving the lives of people with rare diseases of the skin and connective tissue. Fibrocell is utilizing its proprietary autologous fibroblast technology to develop personalized biologics that target the underlying cause of disease.