Scioderm Completes Enrollment of Phase 2b Study of SD-101, a Novel Topical Therapy for Patients with Epidermolysis Bullosa

DURHAM, N.C., April 1, 2014 /PRNewswire/ -- Scioderm, Inc. today announced it has completed enrollment of its Phase 2b study (SD-003) to evaluate the safety and efficacy of SD-101, a novel topical therapy for the treatment of blisters and lesions in patients with Epidermolysis Bullosa (EB.)

Key points:

• Epidermolysis Bullosa (EB) is a rare, genetic connective tissue disorder that typically manifests at birth or early childhood.
• All forms of EB share the common symptom of fragile skin that blisters and tears from the slightest friction or trauma. 
• The Phase 2b study is a prospective, randomized, placebo-controlled trial.
  • Primary endpoint is closure of selected chronic cutaneous wounds in patients with various subtypes of EB (Simplex, Recessive Dystrophic, or Junctional (non-Herlitz)).
  • Additional endpoints include reduction in body surface area (BSA) coverage of lesional areas on the skin and improvement in pain and itching.
  • SD-101 cream is applied over the entire body once daily for a period of three months.
• The trial, which began January 6, 2014, enrolled a total of forty-eight subjects aged six months and older across 7 sites in the U.S.
• Patients completing this study will be eligible to continue receiving SD-101 for daily use (study SD-004). Additional information about studies SD-003 and SD-004 can be found at www.clinicaltrials.gov.

Quotes:

Robert Ryan, Ph.D., president and chief executive officer of Scioderm said, "Scioderm is conducting this multi-site study with dedicated EB clinicians, and together with significant interest from patients with EB, we were able to reach this enrollment milestone at a rapid pace. There is currently no treatment for EB, and we look forward to analyzing the results of this study in the third quarter of this year and improving the lives of those with EB."

Brett Kopelan, executive director of the Dystrophic EB Research Association (debra) of America said, "I would like to congratulate the Scioderm team on full enrollment of their Phase 2b study of SD-101 and attaining this milestone in such a timely fashion. Scioderm's relentless pursuit of innovative therapies offers new hope for caregivers and those living with EB."

About Epidermolysis Bullosa (EB)

Epidermolysis Bullosa (EB) is a rare genetic connective tissue disorder, with many genetic and symptomatic variations. All forms of EB share the common symptom of fragile skin that blisters and tears from 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. 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. 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. SD-101 for the treatment of EB has been granted orphan drug designation in the US and in Europe.  An open-label Phase 2 study in children evaluated SD-101 in target wound reduction and closure, and reduction in body surface area (BSA) coverage of blisters and lesions over a period of three months in children across all subtypes of EB. SD-101 application was well-tolerated and resulted in complete closure of 88% of target chronic lesions within one month, and a 57% reduction in BSA coverage of blisters and lesions after 3 months of daily treatment.

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 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.

Scioderm Investor Contact:
Robert Coull
Chief Operating Officer
(919)-824-2594
[email protected]

Scioderm Media Contacts:                                                   
Andrea Flynn, Ph.D.                                                                
Russo Partners LLC                                                                  
(646) 942-5631                                                                          
[email protected]                                           

Julia Jackson                                                                                       
Cooney/Waters Group                                                              
(212) 886-2249                                                              
[email protected]                                                      

SOURCE Scioderm, Inc.