Amryt has begun with “EASE”, the Phase 3 clinical trial of AP101, its lead drug candidate, which offers a potential treatment for a rare genetic skin disorder that causes fragile skin, Epidermolysis Bullosa (EB).
The company kicked off the first site for EASE in Sydney, Australia, and will randomise the first patient within the next few days. Amryt said it expects to conduct EASE in about 15 countries at over 30 sites to enrol a total of 164 evaluable patients.
EB is a chronic and debilitating condition that causes the skin to blister and tear at the slightest touch and for which there is currently no known cure. There are approximately 500,000 people living with EB worldwide and the global market for a treatment in EB is estimated to be in excess of €1.3 billion.
Mark Sumeray, Chief Medical Officer of Amryt, said: “We are delighted to have initiated the first site participating in our Phase 3 clinical for AP101, which offers a potential treatment for the rare, genetic skin condition, Epidermolysis Bullosa or EB. Our study, EASE, is of substantial size for such a rare disease and offers the opportunity to evaluate a new topical treatment with the potential to accelerate wound healing in this devastating disorder.”