Press Release
New Findings Demonstrate Potential Benefits of GATTEX(TM) (teduglutide) in Phase 3 Study of Patients with Short Bowel Syndrome
Investigators reported that teduglutide achieved a significant increase in absolute intestinal absorption and a decrease in electrolyte losses in SBS patients dependent on parenteral nutrition (PN), with no significant changes observed from baseline for placebo. In addition, new findings demonstrated changes in citrulline, an endogenous non-protein amino acid, appear to be useful biomarkers of PN reduction response when teduglutide is used. Data also suggest that patients with an increase in citrulline at week eight are likely to achieve a significant response, as defined by a greater than 20% reduction in PN. In the third sub-study, investigators reported that with a constant dietary intake, 24 weeks of teduglutide treatment significantly increased energy absorption in PN-dependent SBS patients. GATTEX™ (teduglutide) is a novel investigational compound that may reduce dependence upon PN in patients with SBS, a rare disorder primarily caused by intestinal resection and the subsequent inability to maintain oral fluid, electrolyte, and nutrient balances.
Oral presentations
Abstract 897: “Teduglutide, a Novel GLP-2 Analogue, Decreases Fecal Wet Weight, Sodium and Potassium Excretion in Short Bowel Syndrome (SBS) Patients Dependent on Parenteral Nutrition (PN)” by P. Jeppesen et al.
To quantify the ability of teduglutide to increase absorption, decrease
fecal wet weight and decrease electrolyte losses
With teduglutide, fecal wet weight decreased by 735±574 grams per day at week 24 as compared to baseline (p=0.006). Absolute intestinal absorption, calculated as the weight difference between oral intake and fecal excretion, increased by 795±618 grams per day at week 24. In addition teduglutide decreased electrolyte losses, with decreases in fecal sodium and potassium of 49±30 (p<0.001) and 19±22 (p=0.003) millimoles per liter per day, respectively. Investigators did not observe any significant changes from baseline for placebo.
Abstract 898: “Citrulline: a Potential Predictor of Reductions in Parenteral Nutrition Achieved in Chronic Parenteral Nutrition Dependant Patients with Short Bowel Syndrome (SBS) Treated with Teduglutide” by R. Gilroy et al.
Poster presentation
Abstract T1281: “The Influence of Teduglutide, a Novel GLP-2 Analogue, on Energy Absorption in Short Bowel Syndrome (SBS) Patients Dependent on Parenteral Nutrition (PN)” by P. Jeppesen et al.
To quantify the ability of teduglutide to increase energy absorption, Dr. Jeppesen and colleagues conducted a 72-hour balance sub-study. Twenty-one patients on a standardized diet were reviewed. Investigators calculated absolute energy absorption and relative energy absorption at baseline, week 8, and week 24. Complete data were obtained from 14 of the 21 patients (3 placebo and 11 teduglutide). For those patients who were treated with teduglutide whose dietary energy content did not differ by more than 10% from baseline values (n=6), fecal energy excretion decreased and intestinal absorption increased significantly (p<0.05) at week 8 and at week 24 compared to baseline. Investigators concluded that with a constant dietary intake, six months of teduglutide treatment significantly increased energy absorption in PN-dependent SBS patients.
About GATTEX™ (teduglutide)
GATTEX is a proprietary analog of human glucagon-like peptide 2 that stimulates the repair and regeneration of cells lining the intestine. Patient enrollment is underway in a Phase 3 registration study to confirm previously reported data that demonstrated GATTEX was well tolerated and reduced parenteral nutrition (PN) dependence in short bowel syndrome patients. The international, double-blind, placebo-controlled safety and efficacy study of GATTEX is known as STEPS (Study of TEduglutide in PN-dependent Short-bowel syndrome). More information on STEPS, can be found at http://clinicaltrials.gov.
NPS is also advancing preclinical studies to evaluate teduglutide in additional intestinal failure related conditions.
Teduglutide is currently under investigation for SBS and has not been
approved for marketing by the
About Short Bowel Syndrome (SBS)
SBS is a highly disabling condition that impairs quality of life and can
lead to serious life-threatening complications. SBS typically arises
after extensive resection of the bowel. There are an estimated 10,000 to
15,000 SBS patients in
About DDW
DDW is the largest international gathering of physicians, researchers
and academics in the fields of gastroenterology, hepatology, endoscopy
and gastrointestinal surgery. Jointly sponsored by the
About
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risk of not gaining marketing approvals for GATTEX and NPSP558, the
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Source:
Investors:
NPS Pharmaceuticals, Inc.
Susan M. Mesco,
908-450-5516
smesco@npsp.com
or
Media:
Corporate
Communications Alliance
Edie DeVine, 209-814-9564
edevine@corpcommalliance.com
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