|CHIASMA, INC filed this Form 8-K on 08/09/2018|
titrated from 40 mg per day to up to a maximum of 80 mg per day, equaling two capsules in the morning and two capsules in the evening. Patients meeting predefined biochemical failure criteria in either treatment arm during the course of the trial will be considered treatment failures and revert to their original treatment of injections and will be monitored for the remainder of the trial. The primary endpoint of the trial is the proportion of patients who maintain their biochemical response compared to placebo at the end of the nine-month, double-blind, placebo-controlled period as measured using the average of the last two IGF-1 levels £ 1.0 × ULN. Chiasma continues to anticipate more than 50 clinical sites will be dedicated to CHIASMA OPTIMAL. Chiasma expects the trial to complete randomization by the end of 2018 and anticipates the release of top-line data from this Phase 3 clinical trial in Q4 2019.
MPOWERED Phase 3 Trial
Chiasma is also conducting an international Phase 3 clinical trial of octreotide capsules for the maintenance therapy of adult patients with acromegaly under a protocol accepted by the European Medicines Agency (EMA). The trial, referred to as MPOWERED, is a global, randomized, open-label and active-controlled, 15-month trial. Chiasma has completed enrollment in July 2018 with 135 adult acromegaly patients entered into the run-in phase of the trial, of which it expects to randomize at least 80 patients who are responders to octreotide capsules following a six-month run-in to either octreotide capsules or injectable somatostatin receptor ligands (octreotide or lanreotide), and then followed for an additional nine months. The trial was initiated in March 2016 and is designed to evaluate the proportion of patients who maintain their biochemical response to octreotide capsules and patient-reported outcomes in patients treated with octreotide capsules, compared to patients treated with standard of care injectable somatostatin receptor ligands. Chiasma anticipates the trial to be completed in Q4 2019 and expects to release top-line data from this Phase 3 clinical trial by early 2020.
Second Quarter 2018 Financial Results