Chester County-based Gene Therapy Company Announces First Patient Dosed in Trial for Treatment of Localized Scleroderma

Chester County-based Gene Therapy CompanyCastle Creek Biosciences in Exton, PA

EXTON, PA — Castle Creek Biosciences, Inc, a privately-held, clinical-stage cell and gene therapy company leveraging its proprietary fibroblast technology platform to develop and commercialize innovative personalized therapies for underserved disorders with high unmet medical needs, announced that the first adult patient has been dosed in a Phase 1/2 clinical trial evaluating FCX-013, the company’s investigational gene therapy, for the treatment of moderate to severe localized scleroderma.

“Dosing the first patient is an important milestone in the clinical development program for FCX-013, which we believe has the potential to be the first therapy to treat excessive collagen deposition at the site of localized scleroderma lesions in the skin and soft tissue,” said John Maslowski, Chief Executive Officer of Castle Creek Biosciences. “Our hope is to relieve the debilitating, painful impact of localized scleroderma in patients who currently have limited treatment options.”

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Localized scleroderma is a chronic autoimmune skin disorder that leads to the excess production of collagen and causes thickening of the skin and connective tissue. In moderate to severe forms of the disorder, patients can experience discomfort, tightness and pain that limits their ability to function. Approximately 50,000 patients in the U.S. have moderate to severe localized scleroderma. Current treatment options include systemic or topical corticosteroids that target inflammation, UVA light therapy, and physical therapy. There are no U.S. Food and Drug Administration (FDA) approved therapies for patients living with this disorder.

“Localized scleroderma may be characterized based on the depth and pattern of lesions, and there are currently few treatment options to address the excessive collagen accumulation in the skin and connective tissue,” said Mary Spellman, M.D., Chief Medical Officer of Castle Creek Biosciences. “With our proprietary fibroblast technology, we have an opportunity to develop and evaluate new personalized therapies that are designed for durability and formulated to be compatible with each patient’s unique biology.”

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The open-label, single cohort Phase 1/2 clinical trial is evaluating the safety of FCX-013 as its primary objective. Secondary objectives include assessments of fibrosis at targeted sclerotic lesions at various time points through 26 weeks post-administration of FCX-013. The trial will enroll up to 10 patients with moderate to severe localized scleroderma. More information about the Phase 1/2 trial is available at and searching the identifier NCT03740724.

Castle Creek Biosciences is manufacturing FCX-013 at its in-house, current good manufacturing practices (cGMP), commercial-scale facility located in Exton, Pennsylvania.

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