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news.NPS Pharmaceuticals has completed patient randomisation in a double-blind, placebo-controlled, safety and efficacy Phase 3 Gattex (teduglutide) registration study called Steps.
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NPS Pharma has randomised 86 patients in the Steps trial, evaluating the patients with parenteral nutrition (PN) dependent short bowel syndrome (SBS).
NPS Pharma believes that the positive results from Steps will enable the company to seek US marketing approval for Gattex for patients with PN-dependent SBS.
Francois Nader, president and CEO of NPS Pharma, said: “The timely completion of randomisation in this Phase 3 study marks a milestone in our development program for Gattex in short bowel syndrome.
“We believe Gattex could represent an important advancement in patient care as a potential therapy for reducing parenteral nutrition dependence by rehabilitating the intestine and enhancing nutrient absorption.
“We look forward to delivering our objective of reporting top line results early next year and filing a New Drug Application with the FDA as soon as possible thereafter.”