Amryt presents long-term safety and efficacy data from the open-label extension (OLE) of its global Phase 3 MPOWERED non-inferiority clinical trial that compared Mycapssa® (oral octreotide capsules) to long-acting iSRLs for maintenance of biochemical response in patients with acromegaly. The MPOWERED trial was designed to support the marketing authorization application for Mycapssa® by the EMA which is currently under evaluation. Mycapssa® is approved in the United States for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with injectable octreotide or lanreotide.

MPOWERED Phase 3 Trial– Open-Label Long-Term Safety & Efficacy Data: 60 patients that completed the 15 months core treatment phase elected to continue treatment with Mycapssa® in the MPOWERED open label extension study. During the RCT 19 patients were treated with iSRLs and 35 were treated with Mycapssa®. In addition, 6 patients were treated with a combination of Mycapssa® and cabergoline.

Key study outcomes included: 93%, 91% and 92% of patients completed year 1, 2 and 3 of the OLE, respectively, out of those that entered each year; The average IGF-1 levels of enrolled patients were stably maintained within the normal limits at the end of the OLE period (median IGF-1 levels at Baseline and at the end of the OLE were 0.82 and 0.83 respectively); 86%, 81% and 87% of all patients maintained their biochemical response at year 1, 2 and 3 of the OLE respectively, while utilizing a non-response imputation (any treatment discontinuation is regarded as no-response); 94%, 90% and 93% of patients maintained their biochemical response at year 1, 2 and 3 of the OLE respectively, while utilizing the last observed carried forward (LOCF) imputation in patients treated with Mycapssa® monotherapy; Of patients switching from iSRLs to Mycapssa® during the OLE, 47% reported excellent or very good symptomatic control (5% and 42% respectively) at the end of the Randomized Control Treatment (RCT), increasing to 79% at the end of the OLE (32% and 47% respectively); 58% had at least 3 active acromegaly symptoms on iSRLs at the end of the RTC decreasing to 37% at the end of the OLE after switching to Mycapssa®; In addition, patients treated with iSRLs during the RCT improved when treated with Mycapssa® in the OLE on the Emotional, GI interference, Treatment convenience and Treatment satisfaction domain scores of the Acromegaly treatment satisfaction questionnaire (Acro-TSQ, a validated acromegaly patient reported outcome tool); Acromegaly patients were exposed to Mycapssa® during the OLE for a median treatment duration of 2.2 years and a maximal exposure of 3.5 years. Including the 15 months core treatment phase, 10 patients were treated for more than 4 years and 22 patients for more than 3 years; Patients in the OLE demonstrated a median compliance rate of 99% over this period of time; The long-term safety profile of Mycapssa® during the OLE, was consistent with the safety profile observed during the core study (Run-in plus RCT) with no new safety signals with long- term exposure.