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11-Sep-2018

Amryt receives IND approval from FDA for AP101 enabling the opening of US clinical trial sites

Amryt, a biopharmaceutical company focused on rare and orphan diseases, today announces that the US Food and Drug Administration (“FDA”) has granted Investigational New Drug (“IND”) clearance for AP101. This enables the Company to begin opening US clinical trial sites as part of its ongoing global EASE Phase III clinical trial in Epidermolysis Bullosa (“EB”).

 

EB is a rare genetic skin disorder that can cause skin to blister and tear from the slightest friction or trauma and can, in some cases, cause blistering and erosion of the epithelial lining of internal organs. EB is chronic, potentially disfiguring and life limiting. There are approximately 500,000 people living with EB worldwide and there are currently no approved treatments.1

 

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 and an interim efficacy data readout is due later this year with the top-line data readout expected in Q2 2019.

 

Joe Wiley, CEO of Amryt Pharma, commented: “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.”

 

1https://www.debra.org.uk/what-is-eb/what-is-eb

 

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Last Updated: 11-Sep-2018