Data from MPOWERED phase III trial of Mycapssa to be presented at ENEA 2022

Data presented in a poster presentation of the MPOWERED trial (NCT02685709), a global, randomized, active-controlled non-inferiority study, shows that the time of initiation of Mycapssa relative to the last SRL injection, was not associated with differences in biochemical control, acromegaly symptoms control or patient reported outcomes. A trend was noted for increased adherence to treatment, when Mycapssa was initiated within three weeks (< 3 weeks) following the last injection, compared with the last week of the injection interval (3 weeks).

Dr. Tracy Cunningham, Chief Medical Officer of Amryt, commented: “These data provide important information for physicians when switching patients from injectable SRLs to Mycapssa. The trend towards increased adherence to oral treatment following an early switch, should be further investigated and could be a major advancement in the treatment of patients with acromegaly, who prefer an oral alternative.”

Data highlights from the poster presentation titled, “Outcomes in patients receiving oral octreotide capsules related to time from last SRL injection: analysis from the MPOWERED Phase III study,” include: i. In the MPOWERED phase III trial, Mycapssa could be initiated any time after the last injection up until the time of the next schedule injection +3 days. 40 patients initiated treatment within 3 weeks from the last injection, and 105 patients, initiated Mycapssa greater than 3 weeks from the last injection (=during the last week of the injection interval). ii. Biochemical response, acromegaly symptoms and patient reported outcomes were comparable at the end of the run-in phase, regardless of timing of Mycapssa initiation relative to the prior SRL injection. iii. No new or increased safety signals were identified with a shorter time to initiation of Mycapssa. a. Less patients discontinued treatment in the early initiation group.