(Alliance News) - Amryt Pharma PLC on Wednesday reported positive top line results from its pivotal phase 3 EASE trial of Filsuvez for the treatment of dystrophic and junctional epidermolysis bullosa.
The primary endpoint of the trial was met. EASE is the largest phase 3 trial ever conducted in epidermolysis bullosa, which is a rare, chronic and distressing genetic skin disorder that causes the skin layers and internal body linings to separate. There are currently no approved treatments.
The AIM-listed biopharmaceutical company said the EASE trial was conducted in patients across 58 sites in 28 countries. It comprises a three-month double-blind randomised controlled phase followed by a 24 month open-label, single-arm phase.
Of those that completed the double-blind phase, 100% entered the open label safety follow up phase.
The primary endpoint of the trial was to compare the efficacy of Filsuvez versus control gel according to the proportion of patients with complete closure of the target wound within 45 days of treatment. The primary endpoint was achieved, Amryt said.
Going forward, the company said it will now evaluate and analyse the full data set from the trial and will present results at an upcoming scientific symposium.
"It is very gratifying to see the first results from the trial provide evidence of the effect of Filsuvez on the speed of wound healing in such a complex clinical situation. We look forward to further data over the next few weeks," said Chief Medical Officer Mark Sumeray.
Amryt shares were trading 47% higher in London on Wednesday at 235.90 pence each.
By Evelina Grecenko; evelinagrecenko@alliancenews.com
Copyright 2020 Alliance News Limited. All Rights Reserved.
