Ardelyx Phase 2b Trial Of Tenapanor Meets Primary Endpoint

(RTTNews) - Ardelyx, Inc. (ARDX) Wednesday said its Phase 2b clinical trial evaluating tenapanor in patients with constipation-predominant irritable bowel syndrome or IBS-C met its primary endpoint of an increase in the complete spontaneous bowel movement responder rate. Secondary endpoints, including abdominal pain and other abdominal and IBS-C symptoms, showed clinically meaningful improvements.

The results showed statistically significant and clinically meaningful improvement in IBS-C symptoms for tenapanor-treated patients compared to patients receiving placebo. Tenapanor was well-tolerated, and the safety results were consistent with those observed in previous tenapanor trials, reported the company.

The trial was a Phase 2b, randomized, double blind, placebo-controlled, multi-center study to assess the safety and efficacy of three dose levels of tenapanor in 371 subjects with IBS-C as defined by the Rome III criteria and who had active disease as determined during a two-week screening period.

Tenapanor, a minimally-absorbed inhibitor of the intestinal sodium transporter NHE3, has showed the ability to reduce the absorption of dietary sodium and phosphate. The company had licensed it to AstraZeneca in October 2012.