Topical Cream Granted Breakthrough Therapy for Rare Connective Tissue Disorder

Scioderm announced that the FDA has granted Breakthrough Therapy designation for its investigational topical cream SD-101 for the treatment of patients with inherited Epidermolysis Bullosa (EB). SD-101 is being evaluated for the treatment of skin blistering and erosions caused by EB, including healing skin lesions and reducing the incidence and/or severity of new lesions.

The designation was based on clinical data from a previous open-label Phase 2 study with topical administration of SD-101 in children with either Simplex, Recessive Dystrophic (RDEB), or Junctional EB. The primary outcome measurements were assessments of target wound reduction and closure, and reduction in body surface area (BSA) coverage of lesions and erosions.  The use of SD-101 resulted in complete closure of 88% of target chronic lesions within one month, in addition to a 57% reduction in BSA coverage of lesions and erosions after 3 months of daily treatment.  SD-101 may facilitate the healing of skin lesions and erosions in this serious and potentially life-threatening disease which has a poor prognosis.

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