The first patient has now been enrolled into "EASE", the pivotal Phase III clinical trial which is evaluating AP 101 as a potential treatment for the rare, genetic skin disorder, Epidermolysis Bullosa.- Amryt.
Amryt, is pleased to announce that the first patient has now been enrolled into "EASE", the Company's pivotal Phase III clinical trial, which is evaluating AP 101 as a potential treatment for the rare, genetic skin disorder, Epidermolysis Bullosa ("EB").
As previously reported, EASE intends to study 164 patients across approximately 30 sites in 15 countries, with the first site initiated in Sydney, Australia. Patients will be randomised in a double-blind fashion to AP101 or placebo, with the treatment applied as a topical gel when dressing changes would routinely occur but no less frequently than every four days. The proportion of patients with completely healed target wounds within 45 days will be evaluated as the primary efficacy endpoint. The trial is being conducted by INC Research as the contract research organisation. An interim analysis will be conducted when 50% of the study patients have completed 45 days of treatment. The results from this interim analysis of this trial are expected in the first quarter of 2018.