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news.NPS Pharmaceuticals's Gattex (teduglutide) 24-week randomized, double-blind STEPS Phase 3 pivotal study met the primary efficacy endpoint of reducing parenteral nutrition (PN) dependence in patients with adult short bowel syndrome (SBS).
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The study which was designed to compare the efficacy, safety and tolerability of Gattex to placebo, showed 20% reduction in weekly PN volume at Weeks 20 and 24, compared to baseline.
In an intent-to-treat analysis, 63% (27/43) of Gattex-treated patients responded versus 30% (13/43) of placebo-treated patients.
Patients treated with Gattex for 24 weeks also achieved reductions in weekly PN volume versus placebo.
On an average, patients who received Gattex experienced a 4.4 liter reduction in weekly PN volume from a pre-treatment baseline of 12.9 liters; patients who received placebo experienced a 2.3 liter reduction from a pre-treatment baseline of 13.2 liters.
NPS Pharma president and CEO Francois Nader said they based on these results, they expect to file for FDA approval of Gattex in the second half of this year as a first-in-class treatment for SBS.
"We look forward to reporting additional results from the STEPS study at upcoming medical meetings," Nader said.