Pharmaceutical Business review

NPS reports positive results from Phase III study of Gattex

Results showed that 68% of the 25 patients who had received low-dose Gattex therapy and continued on low-dose Gattex, and 52% of the 27 patients who had received high-dose Gattex therapy and continued on high-dose Gattex achieved a 20% or greater reduction in parenteral nutrition (PN) after a total of 52 weeks of therapy. Patients treated with low-dose Gattex demonstrated a mean 51% reduction in PN volume from pretreatment baseline to the end of 52 weeks of therapy (p< 0.001) and those treated with high-dose Gattex experienced a mean 24% reduction (p< 0.001). The extension study enrolled 65 of the 71 patients (91%) who had completed a 24-week randomized Phase III study that evaluated low-dose Gattex (0.05mg/kg/day) and high-dose Gattex (0.10mg/kg/day) versus placebo. The primary objective of the Phase III extension study was to evaluate the long-term safety and tolerability of daily Gattex dosing for up to 52 weeks (24-week Phase III study and 28-week extension study). Francois Nader, CEO of NPS, said: "We are very pleased with these results, which reinforce our belief that Gattex may be a potential new standard of care for short bowel syndrome (SBS). We continue to communicate with FDA and work with our partner Nycomed to complete the design of the confirmatory Phase III study, which we expect to initiate in the third quarter of 2008."