Clinical Benefits Demonstrated with Low-Dose GATTEX(TM) in Phase 3 Short Bowel Synd...( Conference Call...),Health

Conference Call Today at 9 am ET

BEDMINSTER, N.J., Oct. 11 /PRNewswire-FirstCall/ -- NPS Pharmaceuticals, Inc. (Nasdaq: NPSP) today reported top-line results from the company's Phase 3 study of its investigational drug GATTEX(TM) (teduglutide, recombinant GLP-2) in which 83 patients with short bowel syndrome (SBS) received either a low dose of GATTEX, (0.05 milligrams/kilogram/day), a higher dose (0.10 mg/kg/day) or placebo. The clinical efficacy endpoint of the study was a reduction in parenteral nutrition (PN) of at least 20% comparing baseline to weeks 16 to 24, measured as a graded response to capture reductions up to 100%. In an intent-to-treat analysis, forty-six percent (46%) of patients receiving the lower dose of GATTEX (N=35) responded and achieved a highly statistically significant reduction in PN compared to placebo (p=0.007), with two patients gaining independence from and discontinuing PN by week 20 and a third patient discontinuing PN at the end of treatment. Twenty-five percent (25%) of patients receiving the higher dose of GATTEX (N=32) responded and showed a trend in the difference between the treatment group and placebo, but this did not reach statistical significance (p=0.161). The study's criteria for conducting the statistical analysis of the primary endpoint required that the results for the high-dose group show statistical significance before the results of the low-dose group could be considered. However, given the drug's orphan designation in SBS and the statistically strong (p=0.007) and clinically meaningful findings in the low-dose group, the company intends to meet with the FDA to discuss the path to regulatory approval for GATTEX.

Dr. Stephen O'Keefe, profes
'/>"/>