Amryt shares surge on Filsuvez phase 3 results
Commercial-stage biopharmaceutical company Amryt Pharma announced positive top-line results from its pivotal phase 3 ‘EASE’ trial of ‘Filsuvez’ for the treatment of dystrophic and junctional epidermolysis bullosa on Wednesday.
The AIM-traded firm said the primary endpoint of the trial was met, adding that EASE is the largest phase 3 trial ever conducted in epidermolysis bullosa.
A total of 223 patients were enrolled in the trial, including 156 pediatric patients.
Of those that completed the double-blind phase, 100% entered the open label safety follow-up phase.
The company said 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.
It said the primary endpoint was achieved with statistical significance, representing the first ever successful phase 3 top line readout in epidermolysis bullosa.
The trial was also the fourth time Filsuvez demonstrated accelerated wound healing in a phase 3 trial.
While the key secondary endpoints did not achieve statistical significance, a number of favourable differences were observed, Amryt said.
In addition, substantial further secondary endpoint data was expected, and would be analysed in the coming weeks.
“This positive outcome of the phase 3 EASE trial marks another significant milestone for Amryt as we seek approval for Filsuvez and represents a potentially important advancement for patients and families living with this rare and distressing disorder,” said chief executive officer Dr Joe Wiley.
“If approved, we intend to leverage our existing global infrastructure to commercialize Filsuvez.”
At 1325 BST, shares in Amryt Pharma Holdings were up 50% at 240p.