Parsippany-based Castle Creek Pharmaceutical Holdings, Inc. announced that it reached an agreement to acquire Exton, PA-based Fibrocell Science, Inc., a cell and gene therapy company focused on transformational autologous cell-based therapies for skin and connective tissue diseases.
With the resources of CCP Holdings’ subsidiary, Castle Creek Pharmaceuticals Fibrocell’s gene therapy platform can be advanced into additional areas of high, unmet need with the potential to develop multiple, promising new therapies.
“Our current licensing and development collaboration with Fibrocell, which began in April 2019, has cemented a shared focus on delivering the first approved therapies for families who are impacted by rare dermatologic conditions like epidermolysis bullosa (EB), a chronic, painful and debilitating disease that leads to severe blistering starting early in life and can only be treated with palliative care including extensive bandaging,” said Greg Wujek, chief executive officer of Castle Creek.
“As one company, we will be in a strong position to push forward initially with two late-stage clinical development programs targeting different types of EB with investigational gene and topical therapies, and one potential therapy for scleroderma,” Wujek said.
According to Castle Creek, EB is a rare genetic condition that leads to extremely fragile skin resulting in mild to severe blistering, skin erosion and peeling of the epidermis layers in response to minor injury. There are currently no treatment options approved by the U.S. Food & Drug Administration (FDA) for any form of EB.
Both companies have advanced investigational therapies for the treatment of multiple types of EB into late-stage clinical research. Fibrocell’s lead gene therapy candidate, FCX-007, is being evaluated in a Phase 3 pivotal trial for the treatment of recessive dystrophic epidermolysis bullosa (RDEB).
In addition, Fibrocell said that it is evaluating FCX-013 for the treatment of moderate to severe localized scleroderma in a Phase 1/2 clinical trial. Castle Creek is committed to continuing that research and development. Castle Creek will also continue Phase 2b development of CCP-020 for epidermolysis bullosa simplex (EBS) and other forms of EB.
“Fibrocell’s unique and innovative gene therapy platform provides us with development opportunities that will strengthen the combined company as a leader for EB and other rare conditions where there are limited options for affected patients,” said Mary Spellman, chief medical officer and senior vice president of Research & Development at Castle Creek. “We are truly excited about the future of the new company and the benefits we can bring to patients.”