Successful Phase III T3MPO-2 trial for tenapanor for irritable bowel syndrome with constipation (IBS-C).- Ardelyx.

Ardelyx, Inc. reported positive results from T3MPO-2, its second Phase III study of tenapanor for irritable bowel syndrome with constipation (IBS-C). The study hit statistical significance for the primary endpoint and all secondary endpoints evaluated for the topline results and demonstrated the ability to normalize bowel movements.

The primary endpoint, the combined responder rate for six of 12 weeks, showed that a greater proportion of tenapanor-treated patients compared to placebo-treated patients (36.5% vs. 23.7%, p<0.001) had at least a 30 percent reduction in abdominal pain and an increase of one or more complete spontaneous bowel movements (csbm) in the same week for at least six of the 12 weeks of the treatment period. in addition, tenapanor achieved statistical significance for the csbm and abdominal pain responder rates in the six of 12 and nine of 12-treatment weeks, with a consistent response across the 26 weeks of the study. tenapanor was well-tolerated in treated patients.>

Tenapanor was well-tolerated, consistent with the experience across previous clinical trials. The only adverse events observed in more than two percent of patients in the tenapanor-treated group that were also greater than placebo were diarrhea (16.0% vs. 3.7%), flatulence (3.1% vs. 1.0%), nasopharyngitis (4.4% vs. 3.7%) and abdominal distension (3.4% vs. 0.3%). The placebo adjusted discontinuation rate due to diarrhea was 5.8 percent.

Based on positive results from two positive Phase III trials, Ardelyx is on track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration for tenapanor for the treatment of IBS-C in the second half of 2018. Final, detailed results from the study are expected to be presented at a medical meeting in 2018.

Comment: The previous study results had suggested that tenapanor was slightly less effective than its competitors but the new Phase III data suggest that tenapanor should be able to compete well against its rivals, the guanylyl cyclase C receptor agonists, Allergan Inc./Ironwood Pharmaceuticals Inc.'s Linzess (linaclotide), and Synergy Pharmaceuticals Inc.'s Trulance (plecanatide).