Amryt Pharma’s phase 3 trial, EASE, is the largest phase 3 trial in epidermolysis bullosa.
The British Journal of Dermatology published phase 3 trial results from Amryt Pharma's EASE (NCT03068780) trial of Oleogel-S10 gel for the treatment of epidermolysis bullosa (EB).1 The EASE trial met its primary endpoint of complete target wound closure achieved in 41.3% of target wounds treated with Oleogel-S10 compared to control gel, demonstrating a 44% increase in the probability of wound closure with Oleogel-S10.
Currently, Oleogel-S10 is approved in the European Union and Great Britain for the treatment of partial thickness wounds associated with junctional and dystrophic EB in patients aged 6 months and older.
EASE is the largest phase 3, randomized, controlled study evaluating treatment options for EB. The trial was performed across 58 sites in 28 countries and was comprised of a 3-month double-blind, randomized, controlled phase followed by a 24-month open-label, single-arm phase.
Patients with dystrophic EB and junctional EB target wounds of between 10 and 50cm in size who were present for more than 21 days and less than 9 months were randomized in the double-blind phase to study treatment in a 1:1 ratio and had wound dressings applied according to the standard of care. The trial enrolled 223 patients, including 156 pediatric patients. Out of the patients who completed the double-blind phase, 100% entered the 24-month open-label follow-up phase.
Key trial endpoints include:
According to Amryt, “EB is a rare and devastating group of hereditary disorders of the skin, mucous membranes, and internal epithelial linings characterized by extreme skin fragility and blister development. Patients with severe forms of EB suffer from severe, chronic blistering, ulceration, and scarring of the skin, mutilating scarring of the hands and feet, joint contractures, strictures of the esophagus and mucous membranes, a high risk of developing aggressive squamous cell carcinomas, infections and risk of premature death.” 2