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Positive Phase III Results for Gattex (Teduglutide) in Short Bowel Syndrome

Drug reduced parenteral support and number of infusion days versus placebo (Nov. 29)

Results from the phase III STEPS trial of Gattex (teduglutide, NPS Phamaceuticals), a glucagon-like peptide 2 analog, have been published online in Gastroenterology. The drug was shown to be effective and well-tolerated in reducing the volume of parenteral support and the number of infusion days in patients with short bowel syndrome and intestinal failure (SBS-IF). In the study, patients with SBS-IF were treated with daily subcutaneous dosing of either 0.05 mg/kg teduglutide (n = 43) or placebo (n = 43) for 24 weeks. Parenteral support was reduced if 48-hour urine volumes exceeded baseline values by 10%. The primary efficacy endpoint was the number of patients who achieved a 20% to 100% reduction from baseline in the weekly parenteral support volume at weeks 20 and 24.

There were significantly more responders in the teduglutide group than in the placebo group (27/43 vs. 13/43, respectively; P = 0.002). At week 24, patients who received teduglutide experienced an average 4.4-liter reduction in the weekly parenteral support volume from a baseline value of 12.9 liters. In comparison, 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 the teduglutide-treated patients were able to reduce the number of infusion days per week by 1 or more compared with 23% (9 of 39) of those treated with placebo (P = 0.005).

Two treatment-emergent adverse events leading to discontinuation occurred in the teduglutide group, and three events occurred in the placebo group. The most commonly reported adverse events were gastrointestinal-related. SBS is a disabling condition that can lead to serious, life-threatening complications. The disorder typically arises after extensive resection of the bowel because of Crohn's disease, ischemia, or other conditions. SBS patients often experience malnutrition, severe diarrhea, dehydration, fatigue, osteopenia, and weight loss due to the reduced intestinal capacity to absorb nutrients, water, and electrolytes. The usual treatment for SBS is nutritional support, including parenteral nutrition and/or IV fluids to supplement and stabilize the patient’s nutritional needs.

Although parenteral nutrition can provide nutritional support for SBS patients, it does not improve the body's own ability to absorb nutrients. Parenteral nutrition is associated with serious complications, such as infections, blood clots, and liver damage, and the risks increase the longer patient receives such nutrition.

Gattex (teduglutide) is a recombinant analog of human glucagon-like peptide 2 –– a protein involved in the rehabilitation of the intestinal lining. The drug was developed to reduce the dependence on parenteral nutrition in adult patients with SBS.

Source: NPS Pharmaceuticals; November 29, 2012.

NPS Pharmaceuticals

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