Chiasma's octreotide capsules (conditionally trade named Mycapssa®), are being developed for the 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 has completed an international Phase 3 trial of octreotide capsules, the results of which have been published in the Journal of Clinical Endocrinology and Metabolism. In April 2016, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to the New Drug Application (NDA) for octreotide capsules, indicating that their review is complete and the NDA is not ready for approval in its present form. The FDA has strongly recommended that we conduct a new randomized, double-blind, controlled trial that enrolls patients from the U.S. and is of sufficiently long duration to ensure that control of disease activity is stable at the time point selected for the primary efficacy assessment. While we acknowledge the FDA’s feedback, we continue to evaluate various potential paths forward.
The company is currently conducting, MPOWERED™, an international Phase 3 trial of octreotide capsules for the potential maintenance treatment of adult acromegaly patients to support a potential Marketing Authorization Application with the European Medicines Agency.