Chiasma is a biopharmaceutical company focused on improving the lives of patients who face challenges associated with existing treatments for their rare and debilitating diseases. Employing its Transient Permeability Enhancer (TPE®) technology platform, Chiasma is developing octreotide capsules (conditionally trade named Mycapssa®), as a potential new oral therapy for the maintenance treatment of acromegaly.
Octreotide capsules are in late-stage clinical development, with three global Phase 3 studies at various stages of completion: (1) The CHIASMA OPTIMAL trial is being conducted under a Special Protocol Assessment (SPA) agreement reached with the U.S. FDA; (2) the MPOWERED trial is being conducted under a protocol evaluated and accepted by EMA; and (3) a single-arm, open label Phase 3 trial was completed in 2015, with results published in the Journal of Clinical Endocrinology and Metabolism (JCEM).
CHIASMA OPTIMAL -- Chiasma is conducting a Phase 3 clinical trial under a Special Protocol Assessment agreement reached with the U.S. Food and Drug Administration for its octreotide capsules product candidate for the maintenance therapy of adult patients with acromegaly. The trial, referred to as “CHIASMA OPTIMAL” (Octreotide capsules vs. Placebo Treatment In MultinationAL centers), is a global, randomized, double-blind, placebo-controlled, nine-month trial. It is expected to enroll 50 adult acromegaly patients. The trial is designed to evaluate the proportion of patients who maintain their biochemical response to octreotide capsules compared to placebo. The company initiated enrollment in CHIASMA OPTIMAL in the third quarter of 2017 and anticipates the release of top-line data from this Phase 3 clinical trial in Q4 2019.
MPOWERED™ -- Chiasma also is conducting an international Phase 3 clinical trial under a protocol accepted by the European Medicines Agency (EMA) for the company’s octreotide capsules product candidate for the maintenance therapy of adult patients with acromegaly. The trial, referred to as MPOWERED™ (Maintenance of Acromegaly Patients with Octreotide Capsules Compared with Injections – Evaluation of Response Durability), is a global, randomized, open-label and active-controlled 15-month trial. It has completed enrollment of 135 adult acromegaly patients, of which it expects to randomize at least 80 patients who are responders to octreotide capsules following a six-month run-in to either octreotide capsules or injectable somatostatin receptor ligands (octreotide or lanreotide), and then followed for an additional nine months. Patients are only randomized into the 9-month randomized controlled phase of MPOWERED if they are qualified as responders (IGF-1 <1.3 x ULN and GH<2.5 ng/mL) to octreotide capsules in the study at the end of the six-month run-in phase. The trial was initiated in March 2016 and is designed to evaluate the proportion of patients who maintain their biochemical response to octreotide capsules and patient-reported outcomes compared to patients treated with standard of care injectable somatostatin receptor ligands (octreotide or lanreotide). The company anticipates the release of top-line data from this Phase 3 clinical trial by early 2020.
Completed open label Phase 3 – The company completed an international Phase 3 trial of octreotide capsules, the results of which have been published in JCEM.
Chiasma’s collaboration with healthcare professionals and commitment to acromegaly patients are central to the company’s approach. Chiasma is headquartered in the United States with a wholly-owned subsidiary in Israel.