NPS Pharmaceuticals ($NPSP) says that it's on track to file for regulatory approval of Gattex after a late-stage study involving 86 patients demonstrated promising results for reducing the need for IV feeding among a majority of patients with short bowel syndrome. NPS now plans to file in the second half of the year and the news quickly spurred a 30 percent hike in its stock price in pre-market trading.
Investigators report that 63 percent of patients in the drug cohort demonstrated at least a 20 percent reduction in the need for IV nutrition after 24 weeks of therapy; compared to 30 percent of the patients in the IV group. Short bowel syndrome can occur after a portion of a person's small intestine is removed, hampering the absorption of nutrients. Researchers were forced to go back and mount a new study of Gattex after an earlier trial of a higher dose failed to hit the primary endpoint.
The drug, also known as teduglutide, is an engineered version of the hormone GLP-2. The biotech has estimated that there are about 15,000 people in the U.S. who could benefit from the oprhan drug. And the news helps Nycomed as well, which licensed the ex-North American rights. NPS is holding on to the U.S. market.
"SBS patients who receive their nutrients and fluids intravenously due to malabsorption and diarrhea are prone to a number of serious complications including life-threatening infections, blood clots and liver and kidney damage. The STEPS results suggest teduglutide helps restore normal intestinal function in patients with short bowel syndrome, thereby reducing dependence on parenteral nutrition and potentially improving their quality of life," said Palle Bekker Jeppesen, M.D., associate professor, department of medical gastroenterology, Rigshospitalet, University Hospital of Copenhagen, Denmark.
- see the NPS release
- check out the Reuters story