Amryt announced new positive clinical data from EASE, Phase 3 trial in Epidermolysis Bullosa (EB). These data were presented during a late-breaking oral presentation at the American Academy of Dermatology (AAD) Annual Meeting 2022 held in Boston, MA. Professor Dedee Murrell, M.D. (Chair, Department of Dermatology, St George Hospital, UNSW, Sydney, Australia) was the presenting author of the 12-month interim analysis of the two-year open-label phase (OLP) (n=205) from the EASE trial evaluating the safety and efficacy of Oleogel-S10 in patients with EB. The trial met its primary endpoint in the double-blind phase (DBP; 90 days); target wounds treated with Oleogel-S10 reached first complete wound closure by Day 45 more frequently than wounds treated with control gel, with statistical significance (p=0.013). Patients treated with Oleogel-S10 in the DBP (n=109) experienced a reduction in total body surface area percentage wounding (BSAP) from 12.1% at study entry in the DBP to 7.4% at the end of the DBP. In patients who continued Oleogel-S10 treatment in the OLP (100 of whom were on Oleogel-S10 in the DBP) and who had an OLP Month 12 assessment (n=56), BSAP was further reduced to 5.4% (equates to at least 15 months on Oleogel-S10 treatment). Patients treated with Oleogel-S10 in the DBP (n=109) experienced a reduction in EBDASI skin activity from 19.6 at study entry in the DBP to 16.5 at the end of the DBP. In the patients who continued Oleogel-S10 treatment in the OLP (100 of whom were on Oleogel-S10 in the DBP) and who had an OLP Month 12 assessment (n=55), EBDASI skin activity was further reduced to 15.2 (equates to at least 15 months on Oleogel-S10 treatment). Treatment with Oleogel-S10 was well tolerated with continued use; no new safety signals were observed in the interim OLP analysis.
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