Chiasma Announces Positive Topline Results from the MPOWERED Phase 3 Clinical Trial Comparing MYCAPSSA (octreotide capsules) to Long Acting Injectables for the Maintenance Treatment of Adults with Acromegaly

91% of patients on MYCAPSSA maintained IGF-1 response in the 9-month randomized, controlled phase of the non-inferiority trial

Company intends to submit a marketing application for MYCAPSSA in the EU in mid-2021

Company to host conference call today at 8:00 a.m. ET

NEEDHAM, Mass., Nov. 18, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ: CHMA), a commercial-stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to improve the lives of patients with rare diseases on burdensome and painful injections, today announced positive top-line data from its global Phase 3 MPOWERED non-inferiority clinical trial comparing MYCAPSSA (oral octreotide capsules) to long-acting injectable somatostatin analogs (SSAs) for maintenance of biochemical response in patients with acromegaly. The MPOWERED trial was designed to support a planned marketing authorization application for MYCAPSSA in the European Union. MYCAPSSA is currently approved in the United States for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with injectable octreotide or lanreotide.

The MPOWERED non-inferiority trial was designed to compare long-term maintenance treatment with MYCAPSSA, the first and only approved oral SSA therapy for acromegaly, to the long-acting injectables octreotide long-acting release and lanreotide autogel, in patients previously responding to these therapies. After a six-month run-in phase, 92 patients who were responders to MYCAPSSA were randomized to a nine-month controlled phase with continued treatment on MYCAPSSA or on their prior injectable therapy.

Key Results:

• The study met its primary non-inferiority endpoint. 91% of patients on MYCAPSSA maintained insulin-like growth factor 1 (IGF-1) response (95% CI = 80%, 97%) compared to 100% on injectable SSAs (95% CI = 91%, 100%). Response was defined as the time-weighted average of IGF-1 <1.3 x upper limit of normal (ULN) during the 9-month randomized, controlled treatment (RCT) phase.
• MYCAPSSA maintained mean IGF-1 within normal limits and was comparable to injectable therapy: mean IGF-1 in the MYCAPSSA cohort at the beginning and end of the RCT phase was 0.9 × ULN and 0.9 × ULN, respectively, compared to 0.8 × ULN and 0.8 × ULN, respectively, in the injectable SSA cohort.

“We are excited with the positive results from the MPOWERED study that demonstrated non-inferiority relative to long-acting SSAs. These results further strengthen the available robust clinical data set for MYCAPSSA and provide additional meaningful information for healthcare providers in treating patients with acromegaly,” said Raj Kannan, chief executive officer of Chiasma. “In light of these positive results, we plan to submit a marketing authorization application for MYCAPSSA to the European Medicines Agency in mid-2021. While we are excited to report the preliminary top line results, further analyses of the trial results are ongoing, and we plan to present the full data set from the study at upcoming medical conferences in 2021.”