Skin treatments company Scioderm has raised $1 million in financing as it prepares for clinical trials of an experimental drug addressing a rare genetic skin disease that has no cure or effective treatment.
The financing follows a review last month from the Food and Drug Administration that allowed the Raleigh company’s investigational new drug application for its lead drug candidate, SD-101, to proceed. SD-101 is a topical treatment that Scioderm is developing to treat Epidermolysis Bullosa, or EB. The rare genetic condition results in extremely fragile skin that blisters or tears at the slightest amount of friction. EB also affects internal organs and bodily systems.
Children who have EB have are sometimes called “butterfly children” because their skin is as fragile as the wings of a butterfly. Patients who have the most severe forms of EB experience scarring, disfigurement and disability. They usually die before the age of 30. The only treatment options are wound care, pain management and preventative bandaging.
After announcing the results of the FDA’s review in February, Scioderm said a phase I study would start “in coming months.” A phase 2B/3 study could start in the second half of the year.
Scioderm focuses on developing new treatments for chronic skin diseases. SD-101 is a topical cream that Scioderm says can deliver the active pharmaceutical ingredient across the skin’s various layers. The company believes the experimental treatment has potential uses treating diabetic ulcers and psoriasis. But the company has chosen to pursue EB as SD-101’s first target. Scioderm says the FDA has designated SD-101 as an orphan drug, a designation reserved for new therapies being developed for rare conditions that have few, if any effective treatments. As an orphan drug, approval of SD-101 would qualify for a longer period of exclusivity as well as financial incentives for Scioderm.
Scioderm last year released SD-101 results from an open-label clinical trial, a study in which both the researchers and the patients know which treatment is being administered. Those results showed that application of SD-101 resulted in closure of 85 percent of lesions and a 55 percent reduction in body surface area coverage of lesions and erosions.
The $1 million in financing was raised from two investors, according to the filing. Scioderm’s chairman, CEO and co-founder is Robert Ryan, former chief regulatory officer for Quintiles’ PharmaBio division, the former investment arm of the Durham clinical research organization. Ryan has also held senior regulatory roles at Wilmington-based CRO PPD.