Chiasma provides update on Phase 3 CHIASMA OPTIMAL, MPOWERED trials
Chiasma provided an update on the clinical development of its octreotide capsules product candidate, conditionally trade-named Mycapssa, which is currently being evaluated in two ongoing, international Phase 3 clinical trials for the maintenance treatment of adults with acromegaly, the CHIASMA OPTIMAL and MPOWERED trials. In the Phase 3 CHIASMA OPTIMAL trial, which is being conducted under a special protocol assessment agreement, or SPA, with FDA, the company announced that the last enrolled patient completed the trial earlier this month. The company now expects to release top-line data by mid-Q3. All 56 patients enrolled in the trial reached the final 36-week visit with no patient dropouts from the trial reported through the 36-week double-blind and controlled phase of the trial. In the MPOWERED Phase 3 clinical trial, which is designed to support approval in the European Union, the company also announced that it has also completed enrollment. In October 2018, after 80 patients were randomized into the nine-month controlled phase of the trial, the company elected to resume enrollment in an effort to enroll additional patients exclusively located in the United States in order to gain further U.S. investigator and patient experience with octreotide capsules. Of the 146 total patients that have entered the six-month run-in phase, 84 patients have completed the run-in phase of the trial and were randomized into the nine-month randomized controlled phase, while 10 patients currently remain active in the run-in phase.