TWi Biotechnology has received the designation of Orphan Drug from the FDA for using AC-201 to treat epidermolysis bullosa (EB). TWi Biotechnology has developed proprietary formulations to be used topically for the indication of EB.

Dr. Calvin C. Chen, president of TWi Biotechnology, said, "Epidermolysis Bullosa, or EB, is a very rare genetic connective tissue disorder that affects one child out of every 50,000 births. It is estimated there are approximately 30,000 patients in U.S., and a few hundred children in Taiwan, who suffer from the deliberating disease, which also is known as ‘Butterfly Children’ in the U.S and is called ‘Bubble Dragan Children’ in Taiwan, because patients have extremely fragile skin that blisters and tears from friction or trauma.”

Chen said that many current treatments of EB are focused on the relief of symptoms, such as itching and pain, and are expensive methods like artificial skin, requiring frequent hospital visits. In contrast, the topical formulation of AC-201 is developed to prevent or reduce the blisters.

Clinical trials will soon be initiated.