NPS Drug Gattex Reduces Need for IV Feeding in Patients with Short Bowel Syndrome
Short bowel syndrome (SBS) is a condition caused by either surgical removal of a large portion of the small intestine or a congenital defect in which the portions of the bowel are not present. It results in a malabsorption of nutrients from the digestive tract, requiring the administration of nutrition through intravenous feedings (parenteral nutrition or TPN). An experimental drug in Phase 3 trials has been shown effective in reducing the need for SBS patients to receive IV feedings.
About 10,000 to 15,000 adult patients with Short Bowl Syndrome are chronically dependent on intravenous nutrition in the United States. PN can cost more than $100,000 a year per patient.
Gattex Improves Nutritional Absorption in Intestine
Gattex, also known generically as teduglutide, was developed by NPS Pharmaceuticals based in Bedminster, New Jersey. The drug is an altered version of GLP-2, a naturally-occurring hormone that promotes intestinal growth and enhancement of intestinal function. Gattex works through three mechanisms to improve nutritional absorption: regeneration of the intestinal lining, slowing down transit through the gut, and increasing blood flow.
In a recent Phase 3 trial, 63% of patients who were treated with the injected drug for 24 weeks had at least a 20% reduction in the need for IV nutrition, compared with 30% of patients given a placebo. NPS states that in the trial, which tested a 0.05 mg/kg dose of Gattex, patients given the drug had a 4.4 liter average reduction in weekly parenteral nutrition. Patients with SBS typically receive 12 to 13 liters per week of TPN.
The most common complication from feeding through IV access is bacterial infection and this risk is increased when patients have indwelling central venous catheters, as many patients do who receive long-term parenteral nutrition. Other complications include venous thrombosis (blood clots) and acute cholecystitis (inflammation of the gallbladder).
In the trial, the most common side effects of the drug were nausea and vomiting. One patient dropped out of the study due to an adverse event related to Gattex and three placebo-treated patients also dropped out due to side effects.
Francois Nader, chief executive officer at NPS, says that the company plans to file for US regulatory review of Gattex in the second half of this year. NPS is currently partnered with Swiss drug maker Nycomed to sell the drug outside of North America.