Phase 3 Study Update of Gattex for Adult Short Bowel Syndrome
NPS Pharmaceuticals reported that four additional patients have successfully achieved independence from parenteral nutrition (PN) and intravenous (IV) fluids while on long-term Gattex (teduglutide) therapy in STEPS 2, a 24-month open-label study in adult short bowel syndrome (SBS). SBS is a rare and debilitating condition in which the body is unable to absorb enough nutrients and/or fluids through the gastrointestinal tract and patients chronically depend on PN/IV fluids to survive.
The primary objective of STEPS 2 is to study the long-term safety and durability of effect in patients who completed, participated in, or qualified for participation in STEPS, a 24-week, placebo-controlled, multi-center, international Phase 3 study of Gattex in adult patients with short bowel syndrome. Seventy-six out of the 78 patients who completed 24 weeks of treatment in STEPS elected to enroll in STEPS 2. In addition, 12 patients who successfully completed the optimization and stabilization phase of STEPS opted to enroll in STEPS 2 after STEPS was fully randomized.
To date, seven patients have achieved independence from PN/IV fluids while on Gattex therapy in the ongoing STEPS 2 study. These patients had depended on PN/IV fluids for periods ranging from 2–14 years.
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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