Gattex teduglutide: Phase III data

The double-blind, international Phase III STEPS trial in 86 patients showed that daily 0.05 mg/kg subcutaneous Gattex met the primary endpoint of a significantly 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). Gattex also met the secondary endpoint of significantly reducing mean weekly parenteral nutrition volume from baseline vs. placebo at week 24 (4.4 vs. 2.3 L, p<=0.001). Gattex was well tolerated. NPS said that more than 97% of eligible patients in the STEPS trial are continuing in the open-label STEPS 2 continuation study in which patients will receive Gattex for up to an additional 24 months. ...