Scioderm announced that the US Food and Drug Administration (FDA) has reviewed and allowed the investigational new drug (IND) application for SD-101 to proceed. SD-101 is a topical treatment being developed for the treatment of Epidermolysis Bullosa (EB). The Company plans to initiate a Phase 1 study in the coming months, with initiation of the Phase 2B/3 study in EB patients to occur in the second half of 2013.
EB is a rare genetic condition that in all of its forms, share the prominent manifestation of extremely fragile skin that blisters or tears with the slightest friction or trauma. The disease affects not only the skin but also many internal organs and bodily systems. 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. Wound care, pain management and preventative bandaging are the only options available for caregivers, usually the parents or other family members. The more severe forms of the disease lead to scarring, disfigurement, disability and early death, usually before the age of 30.