Ardelyx reports Phase III tenapanor data in IBS-C

Ardelyx Inc. (NASDAQ:ARDX) said tenapanor (AZD1722, RDX5791) met the primary endpoint in the 12-week, double-blind, placebo-controlled, U.S. Phase III T3MPO-1 trial in 610 patients with irritable bowel syndrome with constipation (IBS-C). Specifically, tenapanor 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 (27% vs. 18.7%, p=0.02). 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.

Tenapanor missed the secondary endpoint of a greater CSBM responder rate for ≥6 of 12 weeks vs. placebo (33.9% vs. 29.4%, p=0.27). The product met the secondary endpoints compared to placebo of a greater abdominal pain responder rate for ≥6 of 12 weeks (44% vs 33.1%, p=0.008); a greater combined responder rate for ≥9 of 12 weeks (13.7% vs 3.3%, p<0.001); a greater CSBM responder rate for ≥9 of 12 weeks (16.9% vs. 5%, p<0.001); and a greater abdominal pain responder rate for ≥9 of 12 weeks (30.3% vs. 19.4% p=0.003)...