NPS Pharmaceuticals, Inc. (NASDAQ: NPSP) a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, today announced the completion of the 24-week treatment phase of the company's Phase 3 registration study of GATTEX® (teduglutide). The double-blind, placebo-controlled safety and efficacy study known as STEPS randomized 86 patients with parenteral nutrition (PN) dependent short bowel syndrome (SBS) to receive drug or placebo over a 24-week treatment period.
"With the last patient's final clinical visit, we remain on track with our development timelines for GATTEX in short bowel syndrome," said Francois Nader, MD, president and chief executive officer of NPS Pharmaceuticals. "We look forward to reporting top line results later this quarter and to filing for marketing authorization with the U.S. Food and Drug Administration if the results are positive."
NPS is also advancing STEPS 2, an open-label continuation study in which all participants will receive up to an additional 24 months of GATTEX therapy. Ninety-seven percent of eligible patients who completed STEPS elected to enroll in STEPS 2.
SBS is a rare disorder characterized by inadequate absorption of fluids and nutrients in people who have had a significant portion of their small intestine removed. Some SBS patients require the use of chronic PN or intravenous feeding to supplement and stabilize their nutritional needs. GATTEX is NPS' proprietary analog of human glucagon-like peptide 2 (GLP-2), a naturally-occurring peptide involved in the repair and maintenance of normal structure and function of the intestine. The goal of treatment with GATTEX is to restore the structural and functional integrity of the remaining intestine to reduce PN dependence.