RALEIGH, N.C., June 19, 2012 /PRNewswire-iReach/ -- Scioderm today announced results from its Phase II clinical trial investigating the efficacy, safety and tolerability of topical administration of SD-101, a dermal pharmaceutical in development for treatment of chronic wounds and lesions in children with various types of Epidermolysis Bullosa. The open label study was conducted in children with either Simplex, Recessive Dystrophic (RDEB), or Junctional EB. Eight children with EB (Simplex, RDEB, or Junctional EB) were enrolled and received daily administration by their caregivers of topically applied SD-101 over their entire body for a period of up to 3 months. The primary outcome measures were assessment of target wound area reduction and closure, and reduction in BSA coverage of lesions and erosions. In the Phase II trial, SD-101 application resulted in closure of 85% of target chronic lesions, in addition to a 55% reduction in BSA coverage of lesions and erosions. SD-101 was well tolerated by the children, with daily administration up to 3 months.
SD-101 has also been designated as an orphan drug by the U.S. Food and Drug Administration for the treatment of Epidermolysis Bullosa (EB). Orphan drug designation provides a number of benefits to the company, including seven years of market exclusivity once SD-101 receives FDA clearance, assistance from the FDA with guiding SD-101 through the regulatory approval process, and waiver or partial payment of application fees and tax credits for clinical testing expenses conducted after orphan designation is received.
Robert Ryan, Ph.D., Chief Executive Officer of Scioderm added, "Epidermolysis Bullosa is a devastating disease. Our results from this trial indicate that SD-101 is a product candidate for treatment of the lesions and blistering on skin in children with EB, who have no other treatment alternatives, and it appears to have a favorable safety profile. We believe these data support the use of SD-101 in EB, and strongly support progression into controlled trials to support registration. We look forward to working with the agency to expedite the continuing clinical testing and regulatory review of SD-101. In addition, we look forward to presenting the full data set at an upcoming scientific conference."
About Epidermolysis Bullosa (EB)
Epidermolysis Bullosa (EB) is a rare genetic skin disease that is characterized by skin that can be so fragile that the slightest friction or trauma can cause severe blistering—inside and outside the body. With skin as fragile as a butterfly wing, EB patients are sometimes referred to as "Butterfly Children". Physical wounds on the skin prevent children from enjoying normal daily activities. The only current treatment for EB is daily wound care management and bandaging, and there is no cure for this disease. Caregivers of these children are typically parents or family members. Constant pain and scarring are often effects seen with EB patients. The severe forms of EB can lead to eventual disfigurement, disability and often early death.
SD-101 is a topical cream that has a number of attributes that may provide clinically important advantages in treating EB along with additional skin diseases including Diabetic Ulcers, based on the ability to deliver the active component of the cream across various skin barriers without systemic absorption. These findings have been demonstrated in both animal and human skin penetration models. Our pre-clinical animal studies have also shown that SD-101 has a good safety and tolerability profile.
Scioderm is a privately-held, clinical-stage pharmaceutical company focused on developing topical products to address critical medical needs in the treatment of chronic skin diseases. Additional information about Scioderm can be found at www.sderm.com.
Robert Ryan, Ph.D.
President and Chief Executive Officer
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 approval and successful commercialization of our products, the inherent risk of failure in developing product candidates based on new technologies, risks associated with the costs of clinical development efforts, as well as other risks. Actual results may differ materially from those projected. These forward-looking statements represent our judgment as of the date of the release. Scioderm disclaims any intent or obligation to update these forward-looking statements.
SOURCE Scioderm, LLC