Trials and registries
Amryt Pharma is currently recruiting patients into its Phase III global clinical trial, EASE, to assess the efficacy and safety of AP101 (Oleogel-S10), as a topical treatment for Epidermolysis Bullosa (EB).
Under the EASE Study, patients are initially randomised to either AP101 (Oleogel-S10) or a placebo topical gel for three months. In addition to either AP101 (Oleogel-S10) or placebo, patients can continue with their choice of non-adhesive dressings. The patients may also choose their preferred frequency of dressing changes, where dressing changes may be performed every day to as little as every four days. This allows them to continue with the routine that suits them best. After three months of treatment with either AP101 (Oleogel-S10) or placebo gel, all patients will receive AP101 (Oleogel-S10) in an open-label safety extension study for two years. The original study protocol can be found HERE.
Amryt Pharma is currently amending the protocol for the EASE Study, having been given the remarkable opportunity by Amicus Therapeutics to review the data from its landmark ESSENCE trial in EB, which read out in September 2017. Amryt is deeply grateful for this unique opportunity and would like to publically recognise and thank Amicus Therapeutics. Based on insights from these data, Amryt will maintain the current primary endpoint, which is the proportion of patients with first complete closure of the target EB wound treated with AP101 versus placebo within 45 days of treatment, and is making certain amendments, the ultimate goal of which is to increase the likelihood of demonstrating a statistically significant treatment effect.
These amendments include a modest increase in the size of the study from 164 to 192 patients and a restriction on certain wound types. The Company will discuss any significant changes with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Amryt Pharma is currently contacting additional EB clinical centres of expertise to consider participation in the study. Ahead of an interim readout halfway through the EASE study, Amryt Pharma anticipates filing an investigational new drug application (IND) with the FDA to allow the opening of study sites in the United States.
If you would like more information regarding the EASE study or wish to consider participating in it, please contact us at: EASEstudy@amrytpharma.com. You can also find details on the EASE study at the following website: clinicaltrials.gov.