Ardelyx to Present Phase 2 Data for Tenapanor in IBS-C Patients at the 2015 American College of Gastroenterology Annual Meeting

Sustained Response Results to Be Featured in Poster Presentation

Oct 08, 2015, 16:30 ET from Ardelyx

FREMONT, Calif., Oct. 8, 2015 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ: ARDX), a clinical-stage biopharmaceutical company focused on gastrointestinal and cardio-renal diseases, today announced that clinical data for the Company's lead product candidate, tenapanor, will be presented at the 2015 American College of Gastroenterology (ACG) Annual Meeting. The presented findings will include measures of sustained response in IBS-C patients enrolled in the Company's 12-week, double blind, placebo-controlled, randomized Phase 2 trial. The meeting will be held in Honolulu, HI, from October 16 through October 21, 2015. The abstract is currently available on the ACG website at http://acgmeetings.gi.org/.

ACG 2015 Poster Presentation:

Title: Tenapanor's Sustained Response in Patients With Constipation Predominant Irritable Bowel Syndrome: Post-hoc Analysis From a 12-Week, Double-Blind, Placebo-Controlled, Randomized Phase 2b Trial, by William D. Chey, Anthony J. Lembo, M.D., David P. Rosenbaum, Ph.D.

Program Number: 1014

Date & Location: Monday, October 19, 2015, 10:00 a.m.-3:30 p.m. Local Time; Exhibit Hall, Hawaii Convention Center

About Irritable Bowel Syndrome with Constipation (IBS-C) 

IBS-C is a gastrointestinal disorder in which abdominal pain or discomfort is associated with constipation, significantly affecting health and quality of life. It is unknown what causes IBS-C. There is no specific test or biomarker for IBS-C, and therefore, its presence is diagnosed by symptoms and by eliminating other disorders. IBS-C is very similar to chronic constipation, but is clinically distinguished by its significant pain component.

Based on reports in the literature regarding the prevalence of IBS in the U.S. population and the percentage of individuals who have IBS-C as opposed to other forms of IBS, Ardelyx estimates that approximately 1.4 percent of the U.S. population has IBS-C, or about 4.4 million individuals. Of those, approximately 1.0 million patients have been diagnosed with IBS-C. Additionally, it is estimated that there are about 6.6 million IBS-C patients in Europe and about 3.4 million patients in Japan.

About Ardelyx, Inc.

Ardelyx is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative, minimally-systemic, small molecule therapeutics that work exclusively in the gastrointestinal tract to treat gastrointestinal and cardio-renal diseases. Ardelyx has developed a proprietary drug discovery and design platform enabling it, in a rapid and cost-efficient manner, to discover and design novel drug candidates. Utilizing this platform, Ardelyx has discovered and designed tenapanor, which it is evaluating for the treatment of IBS-C and for the control of hyperphosphatemia in CKD patients on dialysis. In addition to tenapanor, Ardelyx is developing RDX022, a non-absorbed polymer for the treatment of hyperkalemia, or high potassium, in kidney and heart disease patients. Ardelyx is also advancing several research programs focused in gastrointestinal and cardio-renal diseases. Ardelyx is located in Fremont, California. For more information, please visit Ardelyx's website at www.ardelyx.com.

Forward Looking Statements

To the extent that statements contained in this press release are not descriptions of historical facts regarding Ardelyx, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Reform Act of 1995, including the potential for tenapanor in treating IBS-C and hyperphosphatemia in CKD patients on dialysis, and the potential for RDX022 in treating hyperkalemia in kidney and heart disease patients. Such forward-looking statements involve substantial risks and uncertainties that could cause the development of tenapanor, or Ardelyx's future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in research and the clinical development process. Ardelyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ardelyx's business in general, please refer to Ardelyx's quarterly report on Form 10-Q filed with the Securities and Exchange Commission on August 12, 2015, and its future current and periodic reports to be filed with the Securities and Exchange Commission.

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