NPS Pharmaceuticals, Inc. 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, 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
(SBS-IF) patients.
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).
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.
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