Positive Phase 3 Data on Gattex in Short Bowel Syndrome-Intestinal Failure
NPS Pharmaceuticals announced results from its Phase 3 study of Gattex (teduglutide); the trial, known as STEPS, showed that Gattex is effective and well-tolerated in reducing parenteral support volume and number of infusion days in short bowel syndrome-intestinal failure (SBS-IF) patients. Teduglutide is a novel, recombinant analog of human glucagon-like peptide 2, a protein involved in the rehabilitation of the intestinal lining.
Researchers performed a 24-week study of patients with SBS-IF who were given either daily subcutaneous dosing of 0.05mg/kg teduglutide (n=43) or placebo (n=43). Parenteral support (PS) was reduced if 48-hour urine volumes exceeded baseline values by 10%. The primary efficacy endpoint was defined as the number of patients who achieved a 20%–100% 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=0.002). 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 (P<0.001). After completing 24 weeks of treatment, 54% (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% (9 of 39) of those treated with placebo (P=0.005).
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