NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), a biopharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, announced today that its Phase 3 study of Gattex (teduglutide), a novel analog of glucagon-like peptide 2, has been published online in the peer-reviewed journal,
, 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 (SBS-IF) patients.
“This crucial study demonstrates the potential of Gattex to be an important treatment option for patients with short bowel syndrome,” said Palle B. Jeppesen, M.D., lead author of the study and Associate Professor, Department of Medical Gastroenterology, University Hospital of Copenhagen. “Short bowel patients with intestinal failure rely on parenteral support to meet their nutritional, fluid and electrolyte needs because their intestines aren’t able to absorb enough nutrients, fluids and electrolytes. Being able to reduce or even eliminate dependence on parenteral support should provide important clinical benefits for patients with this debilitating condition.”
Methodology and Results
Researchers performed a 24-week study of patients with SBS-IF who were given either daily subcutaneous dosing of 0.05 mg/kg teduglutide (n=43) or placebo (n=43). Parenteral support (PS) 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 (p<.001).