Ardelyx Inc (NASDAQ:ARDX) Pivotal Phase III Trial Of Tenapanor for IBS-C Hits Primary and All Secondary Endpoints to Support NDA Submission in 2018


Ardelyx Inc (NASDAQ:ARDX) announced promising data from T3MPO-2, its second Phase III trial of tenapanor for IBS-C. The trial hit statistical significance for the initial endpoint and all secondary objectives assessed for the topline data and showcased the ability to normalize bowel movements.

The details

The initial endpoint, the combined responder rate for 6 of 12 weeks, demonstrated that a greater proportion of tenapanor-cured patients assessed to placebo-treated patients had minimum a 30% decline in abdominal pain and a jump of one or more CSBM in the same week for minimum six of the 12 weeks of the therapy period.

Additionally, tenapanor recorded statistical significance for the abdominal pain and CSBM responder rates in the 6 of 12 and 9 of 12-treatment weeks, with a steady response across the 26-weeks of the trial. Tenapanor was well-tolerated in cured patients.

Mike Raab, the CEO and President of Ardelyx, expressed that this data is a game-changer for people with IBS-C, their curing physicians and for Ardelyx as a firm. They showcase the considerable benefit tenapanor can have for people with IBS-C, prominently, resulting in normalization of bowel movements for several patients. This report demonstrates that tenapanor has considerable potential in the market and supports their commitment to list the ideal collaboration partner to assist ensure that they reach the most people possible who would advantage from therapy.

William Chey, M.D., the University of Michigan, reported that IBS-C is an extremely burdensome and tough-to-treat condition affecting over 11 million people in the U.S., and often preventing them from engaging in day-to-day activities, like exercising, going to work and even meeting socially with friends and family.

Depending on tenapanor’s innovative mechanism of action, which depends upon the inhibition of sodium absorption, and the thrilling data announced recently, tenapanor has the prospect to be a new treatment option and an important advancement for people suffering from IBS-C.

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