Ardelyx (ARDX) : positive results of Tenapanor

 

Ardelyx Pivotal Phase 3 study of Tenapanor for IBS-C hits primary and all secondary endpoints to support NDA submission in 2H18

• Co reported positive results from T3MPO-2, its second Phase 3 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 had at least a 30% 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. 
• Based on positive results from two positive Phase 3 trials, Ardelyx is on track to submit a New Drug Application (NDA) to the FDA for tenapanor for the treatment of IBS-C in the second half of 2018.