Amryt Pharma has announced the commencement of “EASE”, the Phase 3 clinical trial of AP101 which offers a potential treatment for Epidermolysis Bullosa (“EB”). Currently there is no known cure for EB, a rare genetic skin disorder which causes the skin to blister and tear at the slightest touch. 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.
Amryt expects to conduct EASE in approximately 15 countries at over 30 sites and to enrol a total of 164 evaluable patients. Patients will be randomised in a double-blind fashion to AP101 or placebo, and the proportion of patients with completely healed target wounds within 45 days will be evaluated as the primary efficacy endpoint.
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.”
He added that the study 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.”