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October 16, 2020
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First patient dosed in gene therapy trial for scleroderma

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The first adult patient has been dosed in a phase 1/2 clinical trial of FCX-013 for the treatment of scleroderma, Castle Creek Biosciences announced in a press release.

FCX-013, an investigational gene therapy candidate, is an autologous fibroblast genetically modified using lentivirus and encoded for matrix metalloproteinase 1, a protein that breaks down collagen. It is being investigated for the treatment of moderate to severe localized scleroderma.

The open-label, single-cohort trial will evaluate the safety of FCX-013, as well as assess fibrosis at targeted sclerotic lesions at various time points through 26 weeks, the release said.

“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,” John Maslowski, CEO of Castle Creek Biosciences, said in the release. “Our hope is to relieve the debilitating, painful impact of localized scleroderma in patients who currently have limited treatment options.”