8:07AM NPS Pharm announces publication of pivotal Phase 3 study of Gattex in short bowel syndrome-intestinal failure patients; Gattex is effective and well-tolerated (NPSP) 9.99 : Co announced that its Phase 3 study of Gattex, a novel analog of glucagon-like peptide 2, has been published online in the peer-reviewed journal, Gastroenterology, the official journal of the American Gastroenterological Association. The 24-week study, known as STEPS, shows that Gattex is effective and well-tolerated in reducing parenteral support volume and number of infusion days in short bowel syndrome-intestinal failure patients.
Researchers performed a 24-week study of patients with SBS-IF who were given either daily subcutaneous dosing of 0.05 mg/kg teduglutide or placebo.
Parenteral support was reduced if 48-hour urine volumes exceeded baseline values by 10 percent.
The primary efficacy endpoint was defined as the number of patients who achieved a 20 to 100 percent reduction in weekly PS volume, from baseline, at Weeks 20 and 24. There were significantly more responders in the teduglutide group (27 of 43) than the placebo group (13 of 43, p=.002). At Week 24, patients who received teduglutide experienced an average 4.4 liter reduction in weekly PS volume from a baseline of 12.9 liters. Patients who received placebo experienced an average 2.3 liter reduction from a baseline of 13.2 liters.
After completing 24 weeks of treatment, 54 percent (21 of 39) of teduglutide-treated patients were able to reduce the number of infusion days per week by one or more days, compared to 23 percent (9 of 39) of those treated with placebo (p=0.005).
The distribution of treatment-emergent adverse events that led to study discontinuation was similar between patients given teduglutide (n=2) or placebo (n=3). The most commonly reported adverse events were gastrointestinal-related and appear to be consistent with the pharmacological effects of the drug.
