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

to analyze dose response.

In the first step of the statistical analysis, the high-dose teduglutide group was compared with the placebo group using a 0.05 significance level. If the high-dose group was not statistically significantly different from the placebo group, no further comparisons would be made. If the high-dose group showed statistical significance, comparisons were to continue to a second analysis step, where the low dose was to be compared with the placebo.

Phase 2 Proof-of-Concept Study Results

In the Phase 2 GATTEX proof-of-concept study, the drug was given by subcutaneous injection for 21 days to 16 patients with SBS. Three patients received 0.03 mg/kg/day, ten patients received 0.10 mg/kg/day, and three patients received 0.15 mg/kg/day. Results of the Phase 2 study indicated that GATTEX was safe and well-tolerated, resulted in intestinal epithelial regeneration and significantly increased intestinal absorption and body weight in parenteral-nutrition-dependent SBS patients.

About SBS

SBS is a condition resulting from the surgical removal of significant portions of the bowel following injury or illness. There are 16,000 to 20,000 adult patients with SBS in the United States. Regulatory authorities in the U.S. and European Union have granted orphan drug status to teduglutide for its potential use, if approved, in treating SBS. Symptoms of SBS include diarrhea, dehydration, malnourishment, and weight loss caused by an inadequate absorption of nutrients and fluids from the diet. Long-term complications of the condition may include an increased risk of systemic infections due to the presence of an intravenous feeding line, degenerative changes in the bones and nerves due to vitamin and mineral deficiencies, and liver failure. Potential benefits derived from reduced dependence on intravenous feeding may include improved nutrition, lower rates of infections, and improved quality of life due to more time away from intravenous feed
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SOURCE NPS Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
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