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ARTICLE | Clinical News

Ardelyx's tenapanor meets in second Phase III for IBS-C

October 13, 2017 7:49 PM UTC

Ardelyx Inc. (NASDAQ:ARDX) plans to submit an NDA to FDA in 2H18 for tenapanor (AZD1722, RDX5791) to treat irritable bowel syndrome with constipation (IBS-C) after reporting that the compound met the primary and secondary endpoints in the Phase III T3MPO-2 trial.

On the 593-patient trial's primary endpoint, twice-daily 50 mg tenapanor for 26 weeks led to a significantly greater combined responder rate, defined as achieving a complete spontaneous bowel movement (CSBM) response and an abdominal pain response during the same week for ≥6 of 12 weeks vs. placebo (36.5% vs. 23.7%, p<0.001). A CSBM response was defined as achieving an increase of ≥1 CSBM from baseline during a week for ≥6 of 12 weeks and an abdominal pain response was defined as achieving a ≥30% reduction in abdominal pain during a week for ≥6 of 12 weeks...