Irish pharmaceutical company Amryt said on Monday that it has received IND approval from the US authorities that will allow it open US clinical trial sites as part of its ongoing clinical trials in epidermolysis bullosa. This comes as part of Amryt’s ongoing global EASE Phase III clinical trial in epidermolysis bullosa, a rare genetic skin disorder that can cause skin to blister and tear from the slightest friction or trauma. Joe Wiley, chief executive of Amryt Pharma, said: “As part of the study design, it was always planned that US trial sites would become part of our EASE Phase III clinical trial. We are pleased with today’s IND clearance from the FDA as it will accelerate patient enrolment into the largest ever global EB trial undertaken. Trial sites are already open across Europe, Australasia, Latin America and the Middle East, with a top-line data readout expected in the second quarter of 2019.

Source: The Irish Times September 10, 2018 06:22 UTC