NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide, today announced that the company has initiated a global registration study of teduglutide in pediatric patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support.
The 12-week, open-label study evaluating teduglutide will be conducted at sites throughout the US and Europe. The primary outcome measures are the number of reported adverse events and changes in parenteral and enteral support requirements, respectively. Additional information about the trial, including a detailed listing of study sites, is available at the National Institutes of Health’s clinical trial registry, which can be found here: http://clinicaltrials.gov/show/NCT01952080
“We are particularly proud to advance teduglutide in pediatric Short Bowel Syndrome, as it may bring us one step closer to fulfilling a significant unmet need among children across the globe who face a life burdened by this rare disease,” said Roger Garceau, MD, FAAP, executive vice president and chief medical officer of NPS Pharmaceuticals. “We look forward to reporting top line results following the completion of the study in late 2014 or early 2015.”
The four-cohort study is expected to enroll up to 36 patients. Non-randomized subjects will receive teduglutide in each of the three active cohorts for 12 weeks. The study will attempt to enroll a fourth cohort of patients in an observational arm that would receive a current standard of care with parenteral support and will be considered a safety control group. All subjects will be screened prior to the start of treatment to establish baseline characteristics including safety, eligibility and nutritional support parameters. Eligibility includes a current history of SBS for a minimum of 12 months prior to screening, which resulted from a major intestinal resection and SBS requiring stable administration of parenteral support for a minimum of three months prior to enrollment, based upon the opinion of the investigator.
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