Press Release
Data Demonstrate That GATTEX(TM) (Teduglutide) Improves Lean Body Mass, Mineral Composition and Electrolyte Levels in Patients with Parenteral Nutrition Dependent Short Bowel Syndrome
Additional Data from Phase 3 Study Presented at the
Data from the randomized, placebo-controlled, 24-week study showed that teduglutide significantly improved lean body mass and total bone mineral content in PN-dependent SBS patients (Abstract P272). A separate presentation showed that teduglutide improves intestinal electrolyte and wet weight absorption in SBS patients (Abstract P273). Previously reported results from the study showed that teduglutide was generally well-tolerated and effective in reducing the PN requirements of SBS patients.
“PN-dependent SBS patients are prone to a number of serious
complications including malnutrition, dehydration and osteoporosis, so
it is very encouraging to see that teduglutide significantly improved
patients’ ability to absorb nutrients, gain lean body mass and more
effectively maintain mineral levels required for healthy bones,” said
The 83 patients in the Phase 3 study all had SBS resulting from major intestinal resection and required PN infusions three or more times per week. Following a 4-16 week optimization and stabilization period, patients were randomized to placebo or one of two dose levels of teduglutide (0.05 or 0.10 mg/kg/d sc) for 24 weeks. PN fluid volume was weaned according to an algorithm based on changes in urine production in relation to teduglutide treatment.
Abstract P272: “Teduglutide (TG), a Dipeptidyl-peptidase IV Resistant Glucagon-like Peptide 2 (GLP-2) Analogue, Improves Lean Body Mass and Total Mineral Content in Short Bowel Syndrome (SBS) Patients Depending on Home Parenteral Nutrition (PN). Dual Energy X-ray Absorptiometry (DEXA) Results from a Randomized, Placebo-controlled, 24-week Study” by P. Jeppesen et al.
In this study, investigators performed Dual Energy X-ray Absortiometry (DEXA) scans of all the patients prior to dosing to compare body composition (total body bone mineral content, fat and lean body mass) at baseline to body composition at the conclusion of the 24-week dosing cycle. The DEXA scans revealed significant improvements in lean body mass and mineral content in patients who received teduglutide compared to those who received placebo. Jeppessen and colleagues concluded the increase in lean body mass may be related to teduglutide-induced improvements in intestinal energy and/or fluid absorption, whereas the improved mineral content may be related to reductions in bone resorption. These effects of teduglutide are desirable in PN-dependent SBS patients, as they are prone to malnutrition, dehydration and osteoporosis.
Abstract P273: “Teduglutide (TG) Improves Electrolyte and Wet Weight Absorption in Short Bowel Syndrome Patients, but this is not correlated to increases in Plasma Citrulline (PC)” by P. Jeppesen et al.
This study was designed to measure the effectiveness of using plasma citrulline (PC) as a biomarker of gut function. In this study, teduglutide increased intestinal wet weight and sodium absorption in SBS patients. Although this was accompanied by an increase in PC, there was no significant correlation between these improvements. Jeppesen and colleagues concluded that while PC may be a surrogate marker of remaining intestinal absorptive cells in SBS patients, balance studies seem to remain the gold standard for measuring intestinal function.
Phase 3 Confirmatory Study
Patient enrollment is ongoing in a second Phase 3 study known as STEPS (Study of TEduglutide in PN-dependent Short-bowel syndrome). STEPS is an international, double-blind, placebo-controlled study to confirm that teduglutide is well tolerated and reduces parenteral nutrition (PN) dependence in short bowel syndrome (SBS) patients. NPS expects STEPS to complete enrollment before the end of the first quarter of 2010.
STEPS will compare daily subcutaneous dosing of 0.05 mg/kg of teduglutide to placebo over a 24-week treatment period. After completing 24-weeks, patients will be offered the option to enter an open-label extension phase (STEPS 2) for up to an additional 24 months, in which patients previously treated with teduglutide or placebo will receive teduglutide.
NPS is advancing STEPS with the support of its partner, Nycomed. In
2007, NPS granted Nycomed the rights to develop and commercialize
teduglutide outside
NPS believes positive results from STEPS will enable it to seek U.S. marketing approval for GATTEX for patients with PN-dependent SBS.
For more information on STEPS, please contact NPS or visit http://www.npsp.com or http://clinicaltrials.gov/ct2/show/NCT00798967?term=teduglutide&rank=2.
About GATTEX™ (teduglutide)
GATTEX is the brand name for teduglutide, a proprietary analog of
naturally occurring human glucagon-like peptide 2 (GLP-2), a peptide
secreted primarily in the distal intestine and involved in the
regeneration and repair of the intestinal epithelium. Preclinical and
clinical studies have demonstrated that GATTEX stimulates the repair and
regeneration of cells lining the small intestine, expanding the surface
area for absorption of nutrients. Given teduglutide’s mechanism of
action to promote gastrointestinal repair, NPS believes it has the
potential to treat gastrointestinal conditions associated with
intestinal failure. Teduglutide is currently under investigation for
short bowel syndrome (SBS) and has not been approved for marketing by
the
NPS is developing GATTEX in
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
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risk of not gaining marketing approvals for GATTEX and NPSP558, the
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Source:
NPS Pharmaceuticals, Inc.
Susan M. Mesco, 908-450-5516 (Investors)
smesco@npsp.com
or
Lazar
Partners Ltd.
Hollister Hovey, 212-867-1762 (Media)
hhovey@lazarpartners.com
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