Amryt Pharma (AIM:AMYT ) said it will present top-line results from its successful Phase 3 EASE trial of FILSUVEZ® at the European Association of Dermatology and Venereology Virtual Congress later this month.
The EASE trial, which is the largest ever global Phase 3 trial conducted in patients with genetic skin disorder Epidermolysis Bullosa, was performed across 58 sites in 28 countries.
The trial, which demonstrated the effectiveness of FILSUVEZ® in accelerating wound healing in people with EB, was described by Amryt as “a very important milestone”. The group is now seeking to approve FILSUVEZ® as a treatment for EB, for which there are currently none.
If FILSUVEZ®, formerly known as AP101 /Oleogel-S10 is approved, Amryt said it will leverage its existing global infrastructure to commercialise the product as a treatment for EB.
The global market opportunity for EB is estimated by Amryt to be in excess of $1.0 billion.
Shares in Amryt Pharma have jumped over 50% since July and were trading this morning at 207p.
The Company said FILSUVEZ® has been granted Rare Pediatric Disease Designation and has also received a Fast Track Designation from the U.S. Food and Drug Administration.
US FDA fast track status is intended to expedite the development of investigational medications and open the treatment to priority review should it come up for approval.
The group said it also intends to pursue an accelerated assessment in the EU. Meanwhile, regulatory submissions in the US and EU are expected to be filed by late Q1 2021.
Amryt said the oral presentation will take place on Saturday October 31, 2020. The Company said it is sponsoring an EB scientific symposium at the congress on the same day.
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