Benzinga | May 27, 2021 04:12PM EDT

Chiasma Highlights Presentation Of Patient-Reported Outcomes Data From MPOWERED Phase 3 Trial At Annual American Association Of Clinical Endocrinology Meeting

Chiasma, Inc. (NASDAQ:CHMA), ("Chiasma" or the "Company") today presented patient-reported outcomes (PROs) data from its MPOWERED(tm) Phase 3 trial demonstrating that study patients with acromegaly reported significantly improved quality of life and work productivity after transitioning from long-acting injectable somatostatin analogs (iSSAs) to MYCAPSSA(r). The data were shared as an oral presentation at the 30th Annual American Association of Clinical Endocrinology (AACE) Meeting being held virtually from May 26-29, 2021.



"The encouraging PROs data from the MPOWERED study further our understanding of the potential positive clinical impact that MYCAPSSA has for patients with acromegaly," said Nienke Biermasz, M.D., Ph.D., Presenting Author. "These PROs provide important information to help physicians assess disease and treatment burden for patients treated with iSSAs and may provide the confidence in MYCAPSSA as a treatment option that can be taken at home and also avoid some of the injection-related issues impacting quality of life and work productivity."

In the MPOWERED study, 146 patients entered the 6-month run-in phase in which all patients received MYCAPSSA. Ninety-two patients who were responders to MYCAPSSA at end of run-in were then randomized into the 9-month randomized controlled treatment (RCT) phase to receive MYCAPSSA or iSSAs. Among the 92 randomized patients, results showed that several PROs, including quality of life and work productivity, were significantly improved at the end of the run-in phase (reflecting outcomes on MYCAPSSA) compared to their results at the baseline of run-in (reflecting outcomes on iSSAs). Significant improvements were observed in the index scores of the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L), a PRO developed to measure quality of life over five domains (mobility, ability to self-care, ability to undertake usual activities, pain and discomfort, and anxiety and depression; mean change from baseline of run-in to end of run-in, 0.053; 95% CI, 0.0130--0.0922). Significant improvements were also seen in comparing baseline of run-in to end of run-in on the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP), a PRO developed to measure work and social activity in clinical trials, for presenteeism (impairment at work/reduced on-the-job effectiveness; least squares mean [LSM], --6.65; 95% CI,--12.39 to --0.90; P=0.024), work productivity loss (LSM, --6.92; 95% CI, --12.83 to --1.02; P=0.022) and activity impairment (LSM, --4.94; 95% CI, --9.17 to --0.71; P=0.022).

William Ludlam, M.D., Ph.D., Sr. Vice President, Clinical Development and Medical Affairs of Chiasma, added, "We are pleased to report data showing that MYCAPSSA represents a treatment option for acromegaly with the potential to positively impact patients whose lives may otherwise be significantly disrupted by injectable therapies. Taken together with the rest of the clinical data set we have generated for MYCAPSSA, these results further support our belief in MYCAPSSA's potential to become the new standard of pharmacological care for the maintenance treatment of acromegaly patients."