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 acromegaly.
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.
Chiasma’s collaboration with healthcare professionals and commitment to patients are central to the company’s approach. Chiasma is headquartered in the United States with a wholly-owned subsidiary in Israel.
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Sharon Merrill Associates