Ardelyx planning NDA for IBS-C candidate

Ardelyx Inc. (NASDAQ:ARDX) plans to submit an NDA to FDA in 2H18 for tenapanor (RDX5791) to treat irritable bowel syndrome with constipation after it said Wednesday that the compound met the primary and secondary endpoints in the Phase III T3MPO-2 trial. Ardelyx shares were up $1.60 (30%) to $7 in early after-hours trading.

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 at least six of 12 weeks vs. placebo (36.5% vs. 23.7%, p<0.001). A CSBM response was defined as achieving an increase of at least one CSBM from baseline during a week for at least six of 12 weeks; an abdominal pain response was defined as achieving at least a 30% reduction in abdominal pain during a week for at least six of 12 weeks...