re able to gain complete independence from and discontinue PN/IV fluids. [16]
01/11/2011 08:47:00
Jan 11: The PIII pivotal STEPS study met the primary efficacy endpoint defined as the % of patients who achieved a ≥20% reduction in weekly PN volume at weeks 20 and 24 vs baseline. In an ITT analysis, 63% (27/43) of teduglutide-treated patients responded vs 30% (13/43) on placebo (p=0.002). Patients treated with teduglutide for 24 weeks also achieved significantly greater reductions in weekly PN volume (4.4L reduction from a pre-treatment baseline of 12.9L) vs placebo (2.3L reduction from a pre-treatment baseline of 13.2L (p ≤0.001). 4 of 86 randomized patients discontinued the study due to AEs (one on teduglutide and 3 on placebo) [13].
31/01/2011 19:30:35
Jan 11: The PIII STEPS has completed the 24-week treatment period. NPS is also advancing STEPS 2, an open-label continuation study in which all participants will receive up to an additional 24 months of therapy. 97% of eligible patients who completed STEPS elected to enroll in STEPS 2 [12].
14/01/2011 15:31:51
Jul 10: The confirmatory 24 week placebo-controlled study PIII STEPS study (NCT00798967) has completed its enrolment of 86 patients with parenteral nutrition-dependent short bowel syndrome. The study is due to complete Dec 10. The primary outcome is the proportion of patients who demonstrate a response (≥20% reduction in weekly parenteral nutrition volume) at week 20 and maintain that response to week 24. The company intend to report the results to the FDA early 2011 and file an NDA soon after [11].
23/07/2010 21:53:00
Oct 09: Further results from the PIII study (n=83) were presented at the American College of Gastroenterology 2009 Meeting. Data from the 24-week study showed that teduglutide significantly improved lean body mass and total bone mineral content in PN-dependent SBS patients (Abstract P272). These effects are desirable as patients are prone to malnutrition, dehydration and osteoporosis. A separate presentation showed that teduglutide improves intestinal electrolyte and wet weight absorption in SBS patients. However, there was no significant correlation between these improvements and levels of plasma citrulline, which was being investigated as a biomarker of gut function (Abstract P273) [10].
28/10/2009 08:43:13
Jun 09: The company expects to complete patient enrolment in the confirmatory PIII STEPS trial before the end of the Q1 2010 (9)
09/06/2009 17:59:01
Jun 09: Further data from the 24 week PIII study in 83 patients with SBS who were dependent on parenteral nutrition (PN) (described below) were presented at the Digestive Disease Week Congress. In the original analysis, teduglutide failed to meet its primary endpoint as the high dose arm (0.10mg/kg/day) did not reduce the need for PN by at least 20% vs. baseline to weeks 16 and weeks 24, although in the low dose arm (0.05mg/kg/day), 46% of patients achieved a statistically significant reduction of PN vs. placebo (p=0.007). The recent data include a study in a subpopulation of 21 patients in whom teduglutide decreased faecal wet weight by 735±574g/d vs. baseline (p=0.006), decreased sodium loss by 49±30 mm/L/day (p<0.001) and decreased potassium loss by 19±22 mm/L/d (p=0.003). In a second substudy, patients who exhibited an increase in endogenous non-protein amino-acid citrulline levels at week 8 were likely to achieve a significant response to teduglutide, suggesting that citrulline represents a go |
