8-K
CHIASMA, INC filed this Form 8-K on 11/08/2018
Entire Document
 
EX-99.1

Exhibit 99.1

 

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Chiasma Reports Third Quarter 2018 Results

Topline Data from Phase 3 CHIASMA OPTIMAL Trial of Octreotide Capsules, Conditionally Trade-Named MYCAPSSA®, Anticipated by September 2019

Company randomizes 80th patient in Phase 3 MPOWERED™ Trial of Octreotide Capsules and Elects to Resume Enrollment of up to an Additional 15 U.S. Patients to Expand Endocrinologist Experience with Octreotide Capsules in the U.S.

Cash sufficient to fund operations through at least the anticipated release of top-line CHIASMA OPTIMAL data while supporting the MPOWERED™ trial in parallel

Waltham, MA – November 8, 2018 – Chiasma, Inc. (NASDAQ: CHMA), a clinical-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today reported financial results for the third quarter ended September 30, 2018 and provided a business update.

On October 1, 2018, Chiasma announced that it had completed enrollment of its international Phase 3 clinical trial, referred to as CHIASMA OPTIMAL (Octreotide capsules vs. Placebo Treatment In MultinationAL centers), randomizing a total of 56 patients. This trial is being conducted under a Special Protocol Assessment (“SPA”) agreement with the U.S. Food and Drug Administration (“FDA”) to support potential regulatory approval in the United States of its investigational octreotide capsules, conditionally trade-named MYCAPSSA®, for the maintenance therapy of adult patients with acromegaly. Chiasma anticipates the release of top-line data from this trial by September 2019.

Chiasma is also currently conducting an international Phase 3 clinical trial, referred to as MPOWERED, of oral octreotide capsules for the maintenance treatment of adult patients with acromegaly to support regulatory approval in the European Union. MPOWERED is a global, randomized, open-label and active-controlled 15-month trial. In October 2018, Chiasma completed the randomization of 80 patients into the nine-month randomized controlled phase of the trial, the minimum amount requested by the European Medicines Agency (“EMA”), from 135 patients who were enrolled into the six-month run-in phase, of which 10 patients currently remain active in run-in. In October 2018, Chiasma elected to resume enrollment in the trial in an effort to enroll up to 15 additional patients exclusively located in the United States in order to gain further U.S. investigator and patient experience with octreotide capsules. As a result of Chiasma’s decision to resume enrollment, the Company now expects to enroll up to the 150-patient enrollment target set forth in the EMA-accepted trial protocol, complete enrollment into the MPOWERED trial in the second quarter of 2019 and to release top-line data from this trial in the second half of 2020.

The Company’s decision to resume enrollment into the MPOWERED trial has no expected impact on the ongoing CHIASMA OPTIMAL trial, or the Company’s planned regulatory activities or timelines associated with the anticipated filing of a U.S. NDA for octreotide capsules. Chiasma continues to believe that the efficacy data from the CHIASMA OPTIMAL trial alone is designed to address the efficacy concerns raised by the FDA in its complete response letter in our first NDA submission and that the FDA only expects to review safety data from the MPOWERED trial as part of its review of our planned NDA resubmission.