NPS Pharmaceuticals, Inc. (NASDAQ:NPSP), a biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide, today announced new findings from its STEPS 2 study supporting the long-term use of Gattex ® (teduglutide [rDNA origin]) for injection in adult patients with Short Bowel Syndrome (SBS). These data were presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting and Postgraduate Course in San Diego, CA.
In the U.S., Gattex is indicated for the treatment of adult patients with Short Bowel Syndrome who are dependent on parenteral support.
STEPS 2 is a two-year open-label extension study of 88 adult patients with SBS. Investigators reported that the long-term use of Gattex in patients with SBS resulted in additional, clinically meaningful reductions in the volume and days per week of parenteral support requirements in this extension study. In addition, 10 of the 13 patients who achieved complete independence from parenteral support were those who received 30 months of Gattex in the 6-month STEPS pivotal study and the 24-month STEPS 2 study. Two patients who received placebo in STEPS and 24 months of Gattex in STEPS 2 and one patient who bypassed STEPS and was enrolled directly into STEPS 2 also achieved independence from parenteral support. No new unexpected safety concerns were observed with long-term Gattex treatment and the product’s safety profile remains consistent with the product’s label.
The poster, entitled “Long-term Safety and Efficacy of Teduglutide for the Treatment of Intestinal Failure Associated with Short Bowel Syndrome: Final Results of the Steps-2 Study, a 2-year, Multicenter, Open-label Clinical Trial,” was recognized as an ACG Presidential Poster Award recipient, which identifies the most highly-ranked abstracts in poster sessions.“We are pleased to see that long-term treatment with Gattex resulted in clinically meaningful reductions in parenteral support as seen in the previous STEPS study,” said Lauren Schwartz, MD, assistant professor of medicine, Mount Sinai School of Medicine, and study investigator. “Further, it is particularly encouraging that 13 patients achieved complete independence from parenteral support with long-term Gattex therapy. The ability to reduce or even completely eliminate the need for parenteral support could meaningfully impact the lives of patients with this rare and debilitating condition.”