Amryt Presents New Analyses from the EASE Phase 3 Trial in Epidermolysis Bullosa at SPD 2022

Amryt Presents New Analys e s from the EASE Phase 3 Trial in Epidermolysis Bullosa at SPD 2022 - Key highlights include efficacy of Oleogel-S10 (birch triterpenes) on accelerated wound healing, data on procedural pain and dressing change frequency, and a 12-month interim analysis of the open-label phase (OLP) , in patients with D ystrophic E pidermolysis B ullosa (DEB) DUBLIN, Ireland, and Boston MA, July 7 , 2022 , Amryt (NASDAQ:AMYT ), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, presented new positive analyses from EASE at the 2022 Society for Pediatric Dermatology (SPD) annual meeting which is being held in Indianapolis on July 7-10. EASE (NCT03068780 ), the largest clinical trial in Epidermolysis Bullosa (EB), is a Phase 3, randomized, controlled, 90-day double-blind, efficacy and safety study of Oleogel-S10 (birch triterpenes) in patients with inherited EB, followed by a 24-month open-label single-arm phase. Analyses of the DEB cohort from EASE will be presented across three poster presentations and demonstrated the following for patients treated with Oleogel-S10: Accelerated wound healing Reduced pain associated with dressing changes and fewer patients required daily dressing changes Sustained improvements in wound burden with a continued reassuring safety profile Dr Tracy Cunningham, Chief Medical Officer of Amryt, commented: "We ar e pleased to present new clinical analyses that support Oleogel-S10 as a potential treatment for DEB patients living wit h this debilitating subtype of EB . These analyses follow an exciting time for patients and their families in the EU who , as a result of the European Commission decision to approve Filsuvez ® in the EU, finally have an approved treatment option available . We are committed to working with other regulatory agencies , including the FDA, to enable more patients to avail of this treatmen t . " Anna Bruckner, MD , University of Colorado School of Medicine, Department of Dermatology , commented : " These new analyses further support Oleogel-S10 's clinical benefit as a well-tolerated and effective therapy for patients with DEB in line with what has been seen in the EASE primary analysis . It is encouraging to see the positive impact that Oleogel-S10 has on patients and their families including accelerated wound healing and less pain during dressing changes . We know that these factors are meaningful to patients during their daily routine living with EB. " Presentation Titles: EASE study demonstrates efficacy of Oleogel-S10 (birch triterpenes) on wound healing in patients with DEB Presenter: Anna Bruckner, MD Oleogel-S10 demonstrated accelerated wound healing in patients with DEB.  The proportion of DEB patients with target wound closure within 45 days was 44.3% on Oleogel-S10 versus 29.6% on control gel (p=0.017). Patients with DEB had sustained improvement in wound burden by Day 90 with Oleogel-S10. Between baseline and Day 90, b ody surface area percentage ( BSAP ) improved to a greater extent with Oleogel-S10 vs. with control gel (-4.4 vs. -2.4), with comparable EBDASI skin activity scores (-3.9 vs. -3.5) . The effect of Oleogel-S10 ... Full story available on Benzinga.com