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Chiasma Announces MPOWERED Phase 3 Clinical Trial Met Its Primary Non-Inferiority Endpoint; Says '91% of patients on MYCAPSSA maintained IGF-1 response in the 9-month randomized, controlled phase of the non-inferiority trial'

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

· 11/18/2020 07:12

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 endpoint91% 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.