New Findings Demonstrate Potential Benefits of NPS Pharma's (NPSP) GATTEX(TM) in Phase 3 Study of Patients with SBS

June 3, 2009 9:15 AM EDT

Clinical investigators presented new data from three sub-studies in patients with short bowel syndrome who received NPS Pharma's (Nasdaq: NPSP) GATTEX(TM) (teduglutide) during a 24-week, placebo-controlled Phase 3 clinical trial. Results were presented at the annual Digestive Disease Week Congress taking place in Chicago.

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, 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(TM) (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 Palle B. Jeppesen, M.D., and colleagues conducted a 72-hour balance sub-study. Twenty-one patients on a standardized diet were included and complete data were obtained from 14 of the 21 patients (3 placebo and 11 teduglutide).

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.

Richard Gilroy, M.D., and colleagues presented results of a sub-study exploring whether changes in citrulline predict reductions in PN in patients receiving 0.05 mg/kg/day of teduglutide, a dose associated with significantly higher response rates when compared to placebo. A clinically significant PN response was defined as a weekly reduction of PN requirements of more than 20% at dosing week 20 and maintained through dosing week 24. In an intent-to-treat analysis 16 of 35 patients (46%) treated for 24 weeks demonstrated a response versus one of 16 in the placebo arm (p=0.007). In this sub-study, investigators examined citrulline, a biomarker of intestinal mass, in the population of patients who had achieved a significant clinical response to see if changes in this biomarker predicted reductions in PN. In this study, there was a correlation between increases in citrulline and reductions in PN. This supports a role for citrulline as a predictor for reducing PN through teduglutide use in SBS patients.

Poster presentation

Abstract T1281: "The Influence of Teduglutide, a Novel GLP-2 Analogue, on Energy Absorption in Short Bowel Syndrome Patients Dependent on Parenteral Nutrition" 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.

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