Phase 3 Study of Gattex for Short Bowel Syndrome in Adults
NPS Pharmaceuticals announced data from the STEPS 2 study of Gattex (teduglutide) for the treatment of short bowel syndrome in adult patients. The primary objective of STEPS 2 was to study long-term safety and durability of effect in subjects who completed, participated in, or qualified for participation in STEPS, a 24-week, placebo-controlled, multicenter, international Phase 3 study of Gattex in adult subjects with short bowel syndrome.
Ninety-one percent of subjects responded after 12 months of Gattex treatment in STEPS 2. A responder was defined as a subject who achieved a 20–100% reduction in parenteral nutrition and intravenous (PN/IV) fluid volume from baseline. Further, 24% of subjects reduced their infusion days per week by three or more days after 12 months of Gattex treatment. Three subjects participating in STEPS 2 were able to gain complete independence from and discontinue PN/IV fluids.
Gattex is a novel, recombinant analog of human glucagon-like peptide 2, a protein involved in the rehabilitation of the intestinal lining.
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