|CHIASMA, INC filed this Form 8-K on 11/08/2018|
During the third quarter, we continued to advance development of our investigational octreotide capsules product candidate for the maintenance treatment of adult acromegaly patients by completing enrollment of 56 patients in our CHIASMA OPTIMAL Phase 3 clinical trial, which should form the basis of an NDA filing, said Mark Fitzpatrick, President and Chief Executive Officer of Chiasma. Our decision to continue the enrollment of an additional 15 patients into the open-label MPOWERED trial will provide valuable real-world investigator and patient experience with octreotide capsules in the U.S. while the double-blind, placebo-controlled CHIASMA OPTIMAL trial is ongoing. The continuation of MPOWERED enrollment will also allow us to focus our limited resources on planned U.S. regulatory activities in 2019 and 2020. The filing, review and approval of a U.S. NDA for octreotide capsules remains our top priority over the next two years, and our U.S. clinical development plan remains on-track.
Third Quarter 2018 Financial Results
CHIASMA OPTIMAL Phase 3 Trial
The CHIASMA OPTIMAL trial is a randomized, double-blind, placebo-controlled, nine-month clinical trial of octreotide capsules being conducted under a SPA agreement with the FDA. The trial enrolled 56 adult acromegaly patients whose disease was biochemically controlled, based upon levels of IGF-1, a byproduct of increased growth hormone (GH) levels caused by acromegaly, by injectable somatostatin analogs at baseline (average IGF-1 £ 1.0 × upper limit of normal (ULN)). The patients also had confirmed active acromegaly following their last surgical intervention based upon an elevated IGF-1 at that time of ³ 1.3 × ULN. The trial is randomized on a 1:1 basis, octreotide capsules versus placebo. Patients are being dose 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 who meet predefined withdrawal 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