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Scioderm Initiates Phase 2B Study of SD-101, A Novel Topical Therapy, for Patients with Epidermolysis Bullosa
Date:1/6/2014

the slightest friction or trauma.  This particular manifestation has led to EB patients being known as "butterfly children" due to the analogous nature of the fragility of the skin to the wings of a butterfly. As of today there is no cure or effective treatment.  The more severe forms of the disease lead to scarring, disfigurement, disability and early death, usually before the age of 30. 

About Scioderm, Inc.

Scioderm is a privately held, clinical-stage pharmaceutical company focused on developing innovative therapies to address diseases with critical unmet medical needs, including orphan products. The company is headquartered in Durham, North Carolina. Additional information about Scioderm can be found at www.sderm.com

About SD-101

SD-101 is a topical cream that has previously demonstrated potential to provide improvement in treating the severe skin effects seen in patients across all EB subtypes. An open-label Phase II study was conducted previously in children with either Simplex, Recessive Dystrophic (RDEB), or Junctional EB.  SD-101 was applied topically over the entire body daily for a period of three months. The primary outcome measurements were assessment of target wound reduction and closure, and reduction in body surface area (BSA) coverage of blisters and lesions.  In the clinical trial, SD-101 application resulted in complete closure of 88% of target chronic lesions within one month, in addition to a 57% reduction in BSA coverage of blisters and lesions after 3 months of daily treatment.   SD-101 was well tolerated by the children.

Forward Looking Statement

Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties, including: our dependence on third parties for the development, regulatory appro
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1. Scioderm Announces Positive Phase II Data of Topical SD-101 on Wound Closure and Reduction of Lesions and Blisters in Children with Epidermolysis Bullosa (EB)
2. Scioderms Investigational New Drug (IND) Application for SD-101 for Treatment of Epidermolysis Bullosa (EB) Allowed by the FDA
3. Scioderms SD-101 Receives Breakthrough Therapy Designation from FDA for Treatment of Epidermolysis Bullosa
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