Chiasma's octreotide capsules (conditionally trade named Mycapssa®), are being developed for the maintenance treatment of acromegaly, a rare, debilitating disease typically caused by a benign tumor of the pituitary gland that releases excess growth hormone (GH), leading to excess growth of certain parts of the body.
We believe octreotide capsules exhibit the effects of somatostatin, a naturally occurring hormone that reduces the production of GH by binding to receptors on specialized cells in the pituitary gland. There are currently no approved oral formulations of octreotide. Octreotide capsules were developed using Chiasma's proprietary Transient Permeability Enhancer (TPE®) technology platform designed to facilitate gastrointestinal absorption of unmodified drug into the bloodstream safely.
The company completed an international Phase 3 trial of octreotide capsules, the results of which have been published in the Journal of Clinical Endocrinology and Metabolism.
Chiasma is conducting a Phase 3 clinical trial, referred to as “CHIASMA OPTIMAL” (Octreotide capsules vs. Placebo Treatment In MultinationAL centers) under a Special Protocol Assessment agreement reached with the U.S. Food and Drug Administration (FDA) to support a potential resubmission of a New Drug Application with the FDA. CHIASMA OPTIMAL 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 by the end of 2019.
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 is expected to enroll up to 150 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 in patients treated with octreotide capsules, 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 in 2020.