Dosing begins in phase 3 trial of recessive dystrophic epidermolysis bullosa gene therapy

The first patient has been dosed in a phase 3 clinical trial of debcoemagene autoficel for the treatment of recessive dystrophic epidermolysis bullosa, Castle Creek Biosciences announced in a press release.

Debcoemagene autoficel (D-Fi, formerly FCX-007) is a gene therapy being developed to address the deficiency of functional type VII collagen protein (COL7) in dystrophic epidermolysis bullosa, the release said. It is delivered intradermally at the site of RDEB wounds.

The multicenter, within-patient randomized, controlled, open-label trial will include 24 subjects whose wounds are paired and randomly assigned to receive D-Fi or remain untreated.

“Our goal is to develop a durable personalized treatment that is compatible with each patient’s unique biology,” Mary Spellman, MD, chief medical officer of Castle Creek Biosciences, said in the release. “We have an opportunity to deliver functional COL7 protein where it is needed — by intradermal administration in wounds of RDEB patients.”