MPOWERED phase III trial of Mycapssa shows benefits in acromegaly.- Chiasma

Chiasma announced the presentation of new positive clinical data from its MPOWERED Phase III trial of Mycapssa (octreotide oral) as the first oral therapy for the treatment of acromegaly. The data from MPOWERED showed that Mycapssa improved clinical symptoms and other patient-reported outcomes compared to long-acting injectable somatostatin receptor ligands (iSRLs) in patients with acromegaly. Mycapssa also met the pre-specified non-inferiority margin compared to long-acting iSRLs in maintenance of biochemical response. Data showed that Mycapssa demonstrated non-inferiority to iSRLs in maintaining biochemical response, 91% (CI, 80%-97%) of the Mycapssa patients maintained insulin-like growth factor 1 (IGF-1) response during the randomized controlled treatment (RCT) phase. Mycapssa demonstrated stable IGF-1 levels during the RCT phase comparable to iSRLs, supporting efficacy of Mycapssa. In addition, a statistically significant reduction from baseline (time of first dose of Mycapssa in run-in) was noted in the number of active acromegaly symptoms. Reduction in the number of active symptoms by individual symptom was statistically significant for swelling of extremities (p = 0.01) and fatigue (p = 0.03). The overall mean symptom score decreased from 4.5 to 3.5; the mean change from baseline was statistically significant and clinically meaningful (> 1 point reduction is equal to a shift of 1 symptom from severe to moderate, or moderate to mild or resolution of 1 symptom). Overall, 80.4% of the randomized patients maintained or improved their symptoms score during the run-in phase compared to baseline. Data were presented at the Endocrine Society’s annual meeting, ENDO 2021, being held virtually March 20-23, 2021.