Chiasma, Inc. to develop and commercialize oral therapies to improve the lives of patients with rare diseases currently treated with burdensome and painful injections, announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of MYCAPSSA® (oral octreotide capsules) as a maintenance therapy for adults with acromegaly. The MAA is supported by positive results from Chiasma’s global Phase 3 MPOWERED™ non-inferiority clinical trial comparing MYCAPSSA to long-acting injectable somatostatin analogs (iSSAs) for maintenance of biochemical response in patients with acromegaly who previously responded to both therapies. MYCAPSSA, the first and only oral somatostatin analog for the treatment of acromegaly approved by the Food and Drug Administration (FDA), is available in the U.S. for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with injectable octreotide or lanreotide. The MPOWERED™ trial was a global, randomized, open-label and active-controlled, 15-month trial intended to support approval of MYCAPSSA® (oral octreotide capsules) in the European Union. This non-inferiority clinical trial was designed to compare MYCAPSSA to long-acting injectable somatostatin analogs (SSAs) for maintenance of biochemical response in patients with acromegaly. The trial enrolled 146 adult acromegaly patients of which 92 patients who were responders to MYCAPSSA after a six-month run-in phase were then randomized to a nine-month controlled (RCT) phase to either receive continued treatment on MYCAPSSA (n=55) or their prior injectable therapy (octreotide long-acting release or lanreotide autogel) (n=37). The primary endpoint of the trial was time-weighted average of IGF-1 <1.3 x upper limit of normal during the nine-month RCT phase. As previously announced, MPOWERED met its primary endpoint of non-inferiority compared to long-acting SSA injectables.