Gattex: Final Extension study data

Final data from the open-label STEPS 2 extension of the double-blind, placebo-controlled, international Phase III STEPS trial in 88 patients with SBS showed that 10 (33%) of 30 evaluable patients who received once-daily 0.05 mg/kg subcutaneous Gattex for 30 months achieved complete independence from parenteral support. In patients who received placebo for 6 months in the STEPS trial followed by 24 months of once-daily 0.05 mg/kg subcutaneous Gattex in STEPS 2, 2 (7%) of 29 patients achieved complete independence from parenteral support. Additionally, 1 (17%) of 6 patients who completed optimization and stabilization in STEPS and were enrolled directly into STEPS 2 to receive Gattex for 24 months achieved complete independence from parenteral support.

Furthermore, 28 (93%) of 30 patients who received Gattex for 30 months, 16 (55%) of 29 patients who received placebo for 6 months followed by Gattex for 24 months and 4 (67%) of 6 patients enrolled directly into STEPS 2 to receive Gattex for 24 months were classified as responders, defined as achieving a >=20% reduction in parenteral support volume from baseline. The average percentage reduction in parenteral support from baseline was 66% in the 30-month arm, 28% for patients receiving 6 months of placebo followed by 24 months of Gattex and 39% for patients enrolled directly into STEPS 2. Data were presented at the American College of Gastroenterology meeting in San Diego. NPS previously reported interim data from STEPS 2 (see BioCentury, Nov. 7, 2011). Previously reported data from the Phase III STEPS trial in 86 patients showed that Gattex met the primary endpoint of a greater proportion of patients who achieved a >=20% reduction in weekly parenteral nutrition volume from baseline to week 20 and maintained that response at week 24 vs. placebo (63% vs. 30%, p=0.002) (see BioCentury, Feb. 7, 2011). ...