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Clinical Benefits Demonstrated with Low-Dose GATTEX(TM) in Phase 3 Short Bowel Syndrome Study
Date:10/11/2007

ebo for six months after an evaluation period of three days to eight weeks and a period of stabilization of four to eight weeks. A total of 71 patients completed the study with a 14.5% dropout rate.

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%.

The dose levels were selected based on the results of the GATTEX Phase 2 proof-of-concept study where doses of 0.03, 0.10 and 0.15 mg/kg/d were administered. Since this study had few subjects in the 0.03 mg/kg/d low dose group, it proved difficult to determine the effects of a low dose. Therefore a low dose of 0.05 mg/kg/d was selected for the Phase 3 study. The highest dose (0.15mg/kg/d) did not seem to provide any additional benefit compared to the 0.10 mg/kg/d dose, therefore the 0.10 mg/kg/d dose was selected as the maximum dose for the Phase 3 study.

Sixteen of the 35 patients (45.7%) receiving the low dose of GATTEX (0.05 milligrams/kilogram/day) demonstrated a 20 percent or greater reduction in parenteral nutrition (PN) (p-value 0.007), compared to eight of 32 patients (25%) in the high-dose group (0.10 mg/kg/day) (p-value 0.161), and one of 16 patients (6%) in the placebo group.

In this Phase 3 study, there were no statistical differences in the incidence rate of adverse events or serious adverse events among the treatment groups when compared to placebo.

Statistical Analysis

The primary endpoint, originally a reduction of 20% or greater in PN measured at weeks 20 to 24, was expanded to account for duration and magnitude of effect. Pair-wise treatment comparisons were made using a rank analysis of covariance with strata for the baseline PN consumption level used for the stratification of the randomization and treatment group with the baseline weekly PN volume as a covariate. A step-down sequential testing procedure was used
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SOURCE NPS Pharmaceuticals, Inc.
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