MRYT ANNOUNCES POSITIVE RESULTS FROM PHASE 3 TRIAL OF FILSUVEZ® IN EPIDERMOLYSIS BULLOSA

LATE-BREAKING ORAL PRESENTATION AT THE 29TH EADV (VIRTUAL) CONGRESS ON OCTOBER 31

Virtual Analyst & Investor Event | Tuesday November 3 at 0830 EST / 1330 GMT Register

, Amryt (Nasdaq: AMYT, AIM: AMYT), a global, commercial-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from serious and life-threatening rare diseases, is pleased to announce positive results from its pivotal Phase 3 EASE trial of FILSUVEZ® (Oleogel-S10/previously AP101). Further to Amryt’s announcement of September 9, 2020, the Company today releases additional data which will be presented as a late-breaking oral presentation on behalf of the trial investigators by Professor Dedee Murrell (Chair, Department of Dermatology, St George Hospital, UNSW, Sydney, Australia) at the 29th EADV (European Association of Dermatology and Venereology) Virtual Congress 2020 on October 31, 2020. The data will also be presented by Amryt at its forthcoming Virtual Analyst and Investor event on November 3, 2020.

Highlights

• The primary endpoint of the trial was met with statistical significance
• The proportion of patients with first complete closure of EB target wound within 45 days was 41.3% in the Oleogel-S10 group and 28.9% in the control group (p value=0.013)
• This translates to a 44% increase in the probability of target wound closure with Oleogel-S10 compared to the control gel
• The proportion of Recessive Dystrophic EB (“RDEB”) patients with first complete closure of EB target wound within 45 days was 44.0% in the Oleogel-S10 group and 26.2% in the control group (nominal p value=0.008)
• This translates to a 72% increase in the probability of target wound closure with Oleogel-S10 compared to the control gel in RDEB patients
• A greater reduction in pain associated with dressing changes was observed in the Oleogel-S10 treatment group at each time point compared with the control group. At Day 14, this difference was nominally significant (p value=0.02)
• There was a greater reduction in total body wound burden as measured by EB Disease Activity and Scarring Index (“EBDASI”) and total body surface area of EB partial thickness wounds with Oleogel-S10 although the differences were not statistically significant
• Oleogel-S10 had an acceptable safety profile and was well tolerated when compared with the control gel

Dr Joe Wiley, CEO of Amryt Pharma, commented: “Today’s announcement of the positive data from EASE marks another significant milestone for Amryt as we seek approval for FILSUVEZ®. These results also represent a potentially important advancement for patients and families living with this rare and distressing disorder. Our existing commercial business is performing and growing and if FILSUVEZ® is approved, we already have the capacity, infrastructure and resources in place to commercialize FILSUVEZ® and our plans for full launch are well advanced.

We would like to extend our gratitude to all of the patients, their families, carers and physicians for their participation in the EASE trial and we look forward to working with regulatory authorities to potentially make FILSUVEZ® available as the first approved treatment for EB patients. The entire team at Amryt is very excited by today’s results and the potential to help patients with this very distressing condition.”

Dr Mark Sumeray, Chief Medical Officer of Amryt commented: “It is very gratifying to see the results from the EASE trial regarding the effect of FILSUVEZ® on the speed of wound healing in such a complex clinical situation. EASE is the fourth Phase 3 trial to demonstrate a statistically significant acceleration in healing of partial thickness wounds and the first in EB. We look forward to progressing our discussions with the respective regulatory authorities as we work to bring FILSUVEZ® to patients.”