NPS Pharmaceuticals, Inc. announced today that it has initiated a pivotal Phase III study with its proprietary investigational drug teduglutide in patients with short bowel syndrome (SBS).
Teduglutide is an analog of glucagon-like peptide 2 (GLP-2), a naturally occurring hormone that regulates the growth, proliferation and maintenance of cells lining the gastrointestinal tract. Teduglutide has been shown in animal studies and previous human clinical trials to increase the size and number of these cells, thereby increasing the absorptive surface area of the intestines.
The multicenter, double-blind, international Phase III trial will randomly assign approximately 80 patients to receive daily subcutaneous injections of 0.05 milligrams or 0.10 milligrams of teduglutide per kilogram of body weight, or a placebo. Dosing will continue for a period of six months. The primary endpoint in the study is a reduction in the use of intravenous feeding, which is often required to sustain life in patients with SBS.
SBS is a condition resulting from the surgical removal of significant portions of the bowel following injury or illness. There are 16,000 to 20,000 adult SBS patients in the United States. Regulatory authorities in the U.S. and the European Union have granted orphan drug status to teduglutide as a treatment for SBS. Symptoms of SBS include diarrhea, dehydration, malnourishment, and weight loss caused by an inadequate absorption of nutrients and fluids from the diet. Long-term complications of the condition may include an increased risk of systemic infections due to the presence of an intravenous feeding line, degenerative changes in the bones and nerves due to vitamin and mineral deficiencies, and liver failure. Potential benefits derived from reduced dependence on intravenous feeding may include improved nutrition, lower rates of infections, and improved quality of life due to more time away from intravenous feeding, which may provide greater mobility and improved sleep. More information about SBS is available on the NPS sponsored website, http://www.shortbowel.com.
In addition to the pivotal SBS study, teduglutide is being tested in a Phase II study in patients with Crohn's disease, an inflammatory condition of the bowel. NPS is currently enrolling patients in this study, which is being conducted at multiple sites in North America.
NPS discovers, develops and intends to commercialize small molecules and recombinant proteins as drugs, primarily for the treatment of metabolic, bone and mineral, and central nervous system disorders. The company's first FDA-approved product, Sensipar(TM) (cinacalcet HCl), is licensed to Amgen Inc. for the treatment of hyperparathyroidism. NPS also has investigational drugs in various stages of clinical development backed by a strong drug discovery effort. Its most advanced product candidate, PREOS, is being developed for the treatment of osteoporosis. Additional information is available on the company's website, http://www.npsp.com.