NPS Pharmaceuticals says that a late-stage study of its experimental drug Gattex (teduglutide) demonstrated promising results for reducing the need for IV feeding among a majority of patients with short bowel syndrome. The late-stage trial involving 86 patients meets primary efficacy endpoint. NPS now plans to file for regulatory approval of teduglutide.
Researchers report that 63 percent of patients in the treatment group showed at least a 20 percent reduction in the need for IV nutrition after 24 weeks of therapy; compared to 30 percent of the patients in the IV group.
Short bowel syndrome, or SBS, is a highly disabling condition that can impair a patient’s quality-of-life and lead to serious life-threatening complications. SBS can occur after a portion of a person’s small intestine is removed, hampering the absorption of nutrients. It was estimated that there are about 15,000 people in the U.S. who could benefit from the orphan drug if approved.
“SBS patients who receive their nutrients and fluids intravenously due to malabsorption and diarrhea are prone to a number of serious complications including life-threatening infections, blood clots and liver and kidney damage. The STEPS results suggest teduglutide helps restore normal intestinal function in patients with short bowel syndrome, thereby reducing dependence on parenteral nutrition and potentially improving their quality of life,” said Palle Bekker Jeppesen, M.D., associate professor, department of medical gastroenterology, Rigshospitalet, University Hospital of Copenhagen, Denmark.