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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

DURHAM, N.C., Jan. 6, 2014 /PRNewswire/ -- Scioderm, Inc. today announced the initiation of a Phase 2B study designed to evaluate the efficacy and safety of SD-101, a novel topical therapy, for the treatment of non-healing wounds in patients with Epidermolysis Bullosa (EB), a rare, genetic connective tissue disorder that typically manifests at birth or early childhood.

"People affected by EB suffer skin blisters, chronic wounds, almost constant pain and itching, and scarring," said Robert Ryan., Ph.D., President and Chief Executive Officer of Scioderm. "The current standard of care is palliative only and focuses primarily on daily wound care, bandaging and pain management. We believe SD-101 has the potential to initiate and continue healing of lesions in this patient population, and Scioderm is committed to develop SD-101 as expeditiously as possible as a treatment option for patients suffering from this devastating condition."

SD-101 for the treatment of EB has been granted an orphan drug designation in the US and in December 2013 received a positive opinion by the Committee for Orphan Medicinal Products (COMP) in the EU.  In addition, Scioderm was the first biotech to receive "Breakthrough Therapy" designation for SD-101 from the Food and Drug Administration (FDA) for the treatment of skin effects in patients with EB.  A breakthrough therapy designation conveys all of the fast track program features, as well as more intensive FDA guidance on an efficient drug development program. In addition, Scioderm was recently selected as  a 2013 "Fierce Top 15" company by FierceBiotech, considered as one of the top 15 emerging companies in the biotech industry. 

The Phase 2B study (SD-003) is a multi-site, prospective, randomized, placebo-controlled trial evaluating the efficacy and safety of SD-101 to close selected chronic cutaneous wounds and reduction in body surface area (
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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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