Orphan Drug Status Granted to Tx for Rare Bowel Disorder
Zealand Pharma announced that their leading product candidate glepaglutide, a potential treatment for short bowel disease (SBS), has been granted Orphan Drug designation.
Glepaglutide is a long-acting GLP-2 analog. A Phase 2 trial demonstrated how glepaglutide treatment was associated with reduced fecal wet weight output as well as indicated increases in energy, fluid and electrolyte absorption.
"The orphan drug designation for glepaglutide enables us to have a closer and more frequent dialogue with the FDA throughout our late stage clinical development," said Britt Meelby Jensen, President and CEO of Zealand. "We are developing [glepaglutide] all the way to the market, and this designation is an important step for us in our efforts to ensure an efficient path to registration and patient access."
Short bowel syndrome is a rare and severe condition with an estimated 20,000-40,000 patients affected in the U.S. and Europe. Patients with the condition have a reduced or complete loss of intestinal function. Currently, patients are treated with parenteral nutrition.
The company aim to begin Phase 3 clinical trials in 2018.
For more information visit ZealandPharma.com.