|CHIASMA, INC filed this Form 8-K on 08/09/2018|
Chiasma Reports Second Quarter 2018 Results
Recent Highlights Include Completion of Enrollment of MPOWERED Phase 3 Trial and
50% Randomization in CHIASMA OPTIMAL Phase 3 Trial
WALTHAM, Mass., August 9, 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 second quarter ended June 30, 2018 and provided a business update.
We have made meaningful progress on our plan to advance the development of octreotide capsules, conditionally trade-named MYCAPSSA®, as an oral maintenance treatment for adult patients with acromegaly, said Mark Fitzpatrick, president and CEO of Chiasma. We successfully enrolled 135 acromegaly patients into the six-month run-in phase of our MPOWERED Phase 3 trial, and we now expect to complete this trial in Q4 2019, with release of top-line data by early 2020. We also surpassed 50% enrollment in our CHIASMA OPTIMAL Phase 3 trial, an important step toward our goal of submitting a New Drug Application with the FDA. We strongly believe in MYCAPSSA as a potential new treatment option for adults with acromegaly, and we are encouraged by the achievement of these important milestones.
The Company expects that its existing cash and investments will be sufficient to fund its operations through the anticipated release of top-line data from the CHIASMA OPTIMAL clinical trial in Q4 2019 while supporting the MPOWERED trial in parallel.
CHIASMA OPTIMAL Phase 3 Trial
Chiasma is conducting a randomized, double-blind, placebo-controlled, nine-month clinical trial of octreotide capsules which is expected to enroll 50 adult acromegaly patients (at least 20% of whom must be recruited from the United States) under a Special Protocol Assessment with the U.S. Food and Drug Administration (FDA). The trial, referred to as CHIASMA OPTIMAL, is enrolling acromegaly patients whose disease is biochemically controlled, based upon levels of IGF-1, a byproduct of increased growth hormone (GH) levels caused by acromegaly, on injectable somatostatin analogs at baseline (average IGF-1 £ 1.0 × upper limit of normal (ULN)). The patients also must have 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 being randomized on a 1:1 basis to octreotide capsules or placebo. Patients are being dose