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Currently there is no cure or effective treatment for EB, which affects children beginning at birth and presents with the prominent manifestation of extremely fragile skin that blisters or tears with the slightest friction or trauma. The more severe forms of the disease lead to scarring, disfigurement, disability and early death, usually before the age of 30.
The study is scheduled to enroll the first patient in January 2014, and is expected to enroll 36 patients at seven sites in the U.S. The Phase IIb trial will evaluate the safety and efficacy of SD-101, a topical cream which has previously demonstrated potential to provide improvement in treating the severe skin effects seen in patients across the primary inherited EB subtypes. Specifically, the trial will examine the safety and efficacy of SD-101 with a primary endpoint of target lesion closure at one month of treatment.
Scioderm President and Chief Executive Officer Dr. Robert Ryan noted, “Novella Clinical was a natural fit for this trial due to its therapeutic experience within dermatology and wound care, in addition to the company’s commitment to emerging biotechs. Novella offers the flexibility and transparency critical to Scioderm at this point in our development.”
Durham, North Carolina-based Scioderm recently became the first biotech to secure Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for SD-101 for the treatment of skin effects in patients with inherited EB. Breakthrough designation provides for fast track status as well as intensive FDA guidance for the SD-101 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.