Irish pharmaceutical company Amryt said on Monday that it had received IND (investigational new drug) approval from the US authorities that will allow it open clinical trial sites as part of its ongoing clinical trials in epidermolysis bullosa.
Amryt said the Food and Drug Administration (FDA) had given the biopharmaceutical company, focused on rare and orphan diseases, IND approval 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. About 500,000 people are living with EB worldwide and there are currently no approved treatments.
Amryt Pharma chief executive Joe Wiley 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 an Ease phase III clinical trial, 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.