[5] In Scioderm's initial open-label Phase 2 study conducted in children with either Simplex, Recessive Dystrophic (RDEB), or Junctional EB, the application of SD-101 resulted in complete closure of 88% of target chronic lesions within one month, in addition to a 57% reduction in Body Surface Area (BSA) coverage of lesions and erosions after 3 months of daily treatment.
[6][7] SD-101, now owned by Amicus Therapeutics, is currently in Phase 3 clinical development to evaluate Zorblisa as a therapy for the treatment of lesions and blistering associated with Epidermolysis Bullosa.
[9] In April 2013 Scioderm received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for its topical treatment, SD-101 for Epidermolysis Bullosa.
[14][15][16] Coull and Ryan "acquired the asset from another firm, which had demonstrated a wound healing effect at a lower concentration of the active ingredient before the topical [treatment's] advancement was stalled by lack of funding.
[17] On August 31, 2015, Amicus Therapeutics announced the acquisition of Scioderm in a deal valued at approximately $950 million based on the achievement of certain milestones.