NPS Pharmaceuticals announced that its Phase 3 pivotal study of Gattex (teduglutide) met the primary efficacy endpoint of reducing parenteral nutrition (PN) dependence in patients with adult short bowel syndrome (SBS). This study, also known as STEPS, was an international, double-blind, placebo-controlled study designed to provide additional evidence of safety and efficacy of Gattex in reducing PN dependence in adult SBS patients. The study reached statistical significance for the primary efficacy endpoint, defined as the percentage of patients who achieved a 20% or greater reduction in weekly PN volume at Weeks 20 and 24, compared to baseline. In an intent-to-treat analysis, 63% (27/43) of Gattex-treated patients responded versus 30% (13/43) of placebo-treated patients (p=0.002). Patients treated with Gattex for 24 weeks also achieved significantly greater reductions in weekly PN volume versus placebo.
Gattex is a recombinant analog of human glucagon-like peptide 2, a protein involved in the rehabilitation of the intestinal lining.
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