UK's Amryt to Open US Clinical Trial Sites for Epidermolysis Bullosa

Sep 10, 2018
By Pharmaceutical Executive Editors
Amryt (London, UK) , a biopharmaceutical company focused on rare and orphan diseases, today announces that 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.
 
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. 
 
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