Scioderm Initiates Phase IIB Study

Scioderm, Inc. recently announced the initiation of a Phase IIB 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, PhD, President and CEO 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 US 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.

The Phase IIB 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 (BSA) coverage of lesional areas on the skin in patients with EB [Simplex, Recessive Dystrophic, or Junctional (non-Herlitz)]. In addition, improvement on pain and itching will also be assessed. Approximately 48 subjects aged 6 months and older are planned to enroll in the trial, which is being conducted in 7 sites across the US. The study will comprise application of SD-101 cream over the entire body daily for a period of 3 months. Patients completing the study will be eligible to continue receiving SD-101 when the study is completed. Additional information about Study SD-003 can be found at www.clinicaltrials.gov.

“Our patients with EB have few therapeutic options available, and none have demonstrated evidence of accelerated closure of chronic wounds, said the study’s Principal Investigator, Amy Paller, MD, Walter J. Hamlin Professor and Chair of the Department of Dermatology, Northwestern University Feinberg School of Medicine. “We look forward to testing this new potential intervention in the double-blind, randomized trial. If the lives of the EB patients are improved with topical use of SD-101 through faster wound healing, as well as decreased pain and itchiness, this cream would be welcomed by our affected families.”

“We are very excited that Scioderm has developed this potential therapy to treat some of the more profound symptoms of EB,” added Brett Kopelan, MA, Executive Director of the Dystrophic Epidermolysis Bullosa Research Association of America (debra of America). “The impact on the quality of life of those with EB would be immeasurable if SD-101 was to be proven safe and effective.”

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, NC. For more information, visit www.sderm.com.