Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects (STEPS)

In January 2011, NPS reported positive top-line results from a Phase 3 registration study, known as STEPS, in adult short bowel syndrome (SBS).  The study reached statistical significance for the primary efficacy endpoint, defined as the percentage of patients who achieved a 20 to 100 percent reduction in weekly parenteral nutrition (PN) volume at Weeks 20 and 24 compared to baseline.  In an intent-to-treat analysis, 63 percent (27/43) of GATTEX-treated patients responded versus 30 percent (13/43) of placebo-treated patients (p=0.002).  STEPS was an international, double-blind, placebo-controlled study desinged to provide additional evidence of safety and efficacy of GATTEX in reducing PN dependence in adult SBS.  For more information on STEPS, please click here.

Use of NPSP558 in the Treatment of Hypoparathyroidism (REPLACE)

Patient randomization is complete in a Phase 3 registration study, known as REPLACE, evaluating NPSP558, our proprietary recombinant, full-length (1-84), human parathyroid hormone, for the treatment of hypoparathyroidism.  The primary objective is to demonstrate, over a 24-week treatment period, that once-daily subcutaneous dosing with NPSP558 at doses of 50µg, 75µg or 100µg is a safe and effective hormone replacement therapy for the treatment of patients with hypoparathyroidism.  For more information on REPLACE, please click here.