Ardelyx Reports Positive Results from Its Phase 2b Clinical Trial Evaluating Tenapanor in IBS-C Patients

October 1, 2014 10:07 AM

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FREMONT, Calif., Oct. 1, 2014 /PRNewswire/ -- Ardelyx, Inc. ARDX, -1.25% a clinical-stage biopharmaceutical company focused on cardio-renal, gastrointestinal and metabolic diseases, today announced positive results from its 371 patient Phase 2b clinical trial evaluating tenapanor in patients with constipation-predominant irritable bowel syndrome (IBS-C). Results from this study demonstrated statistically significant and clinically meaningful improvement in IBS-C symptoms for tenapanor-treated patients compared to patients receiving placebo. At the 50 mg dose, the study met its primary efficacy endpoint of an increase in the complete spontaneous bowel movement (CSBM) responder rate. Most secondary endpoints, including abdominal pain and other abdominal and IBS-C symptoms, demonstrated clinically meaningful improvements. Tenapanor was well-tolerated, and the safety results were consistent with those observed in previous tenapanor trials.

"We are pleased to see that tenapanor continues to demonstrate the degree of activity that was shown in the Phase 2a clinical trial for IBS-C," said Mike Raab, President and CEO of Ardelyx. "We are excited about the potential for tenapanor in IBS-C. We will work with our partner, AstraZeneca, to de...

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