Scioderm, a Durham-based biopharmaceutical company that closed on a $20 million round of funding in December, announced Thursday that it has begun registering patients for the Phase 3 trial of its experimental treatment for Epidermolysis bullosa, or EB.
EB is a genetic connective-tissue disorder that prevents skin layers from binding properly; the result is fragile skin that causes unbearable itching, excruciating pain and eating complications that can require the use of feeding tubes.
Scioderm’s therapy, Zorblisa, is a skin cream that causes the wounds to heal quicker and heals wounds that normally would fester. It does not treat the underlying genetic causes of the disorder.
“Initiating this study is an important milestone for the EB community and for our Zorblisa clinical development program,” said Robert Ryan, Scioderm’s CEO, in a statement.
Phase 3 trials are the final stage of testing required before Scioderm can seek regulatory approval to put the drug on the market.
Scioderm's therapy has received "breakthrough therapy designation" status from the U.S. Food and Drug Administration. The designation, intended to expedite development of medicine for life-threatening conditions, is given to drugs that have demonstrated early proof of substantial improvement in available treatment.
The company’s $20 million Series B round was led by Redmile Group. Other investors included Morganthaler Ventures and Technology Partners.