Amryt gets green light for EB treatment

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.

Amryt said that the US Food and Drug Administration (FDA) has given the biopharmaceutical company, focused on rare and orphan diseases, Investigational New Drug (IND) for AP101, which will enable the opening of US clinical trial sites.

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. There are about 500,000 people living with EB worldwide and there are currently no approved treatments.

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. Moreover, the FDA’s decision is positive news for eligible American sufferers of this rare condition who can now participate in the study."

AP101 is currently in a Phase III clinical trial (EASE), the largest ever global Phase III study conducted in patients with EB. 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.