Data for Mycapssa from OPTIMAL and MPOWERED Phase III Trials presented at ENDO 2022.
Amryt presented positive clinical data from the open-label extensions (OLEs) of two of the Phase III trials of Mycapssa (oral octreotide), OPTIMAL and MPOWERED , at the Endocrine Society’s annual meeting, ENDO 2022.
Data presented in a late-breaking poster presentation of the 2nd year of the OLE of OPTIMAL (NCT03252353), a randomized, double-blind placebo-controlled (DPC) trial, further support the long-term safety and efficacy of Mycapssa in acromegaly patients who were previously biochemically controlled on monthly injectable somatostatin receptor ligands (iSRLs). Additionally, data presented in a poster presentation of the OLE of MPOWERED (NCT02685709), a global, randomized, open-label and active-controlled non-inferiority study, shows improvements in symptom control and patient-reported outcomes in people with acromegaly that received Mycapssa upon entering the OLE from the iSRL arm in the randomized phase.
Data highlights from the late-breaking poster presentation titled, “Second Year Outcomes of the Open-Label Extension of OPTIMAL, a Phase III Study of Oral Octreotide Capsules in Acromegaly,” include: i. Maintenance of biochemical response (defined as insulin-like growth factor I [IGF-I] levels of less than the upper limit of normal [ULN]) to Mycapssa was durable up to 96 weeks. 100% of subjects (n= 17) who were responders at week 48 and 93% of subjects overall (n=29) demonstrated a biochemical response at week 96. ii. Median exposure to Mycapssa was 2.1 years, with exposure greater than 3 years for 5 patients. iii. Mycapssa’s safety profile was consistent with previous studies throughout the OLE; no serious adverse events were reported.
Data highlights from the poster presentation titled, “Long-term Efficacy and Safety Data for Oral Octreotide Capsules in Acromegaly: MPOWERED Trial Open-Label Extension Phase,” include: i. For each of the three full years of the OLE’s duration, 90% or more of participating subjects met the OLE’s primary endpoint of maintaining a biochemical response to Mycapssa (defined by IGF-I levels of less than 1.3 times the upper limit of normal [ULN]) at the end of the year after responding at the start of the year. ii. Patients switching from iSRLs in the RCT (randomized control treatment) phase to Mycapssa during the OLE demonstrated the following: a. 79% reported very good (47%) or excellent (32%) symptom control at the end of the OLE, compared with 47% (42% very good or 5% excellent) at the end of the RCT phase while receiving iSRLs. b. Significant improvements in the treatment convenience and treatment satisfaction domains (both P<0.05) of the acromegaly treatment satisfaction questionnaire.
No new safety signals were observed with long-term Mycapssa use compared to the core treatment phase.