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Ardelyx's gastrointestinal drug meets main goal in 2nd phase 3 study


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Ardelyx's gastrointestinal drug meets main goal in 2nd phase 3 study

Ardelyx Inc.'s investigational drug Tenapanor met its main goal in a phase 3 study for treating patients with irritable bowel syndrome with constipation.

Irritable bowel syndrome with constipation is a gastrointestinal disorder resulting in significant abdominal pain and constipation.

Ardelyx said the study achieved statistical significance for the primary endpoint and all secondary endpoints and showed that the drug was able to normalize bowel movements.

The results showed that 36.5% of patients given Tenapanor saw at least a 30% reduction in abdominal pain and an increase of one or more complete spontaneous bowel movements, compared with 23.7% of patients given placebo.

Previously, Ardelyx reported positive top-line results from another phase 3 trial in May, with a third ongoing long-term safety trial expected to conclude in late 2017.

The company is expected to submit a new drug application to the U.S. Food and Drug Administration in the second half of 2018, based on results from the two phase 3 trials.

Ardelyx President and CEO Mike Raab said the results would boost the company's commitment to identify a collaboration partner to commercialize the therapy.