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July 03, 2015 1:24 PM ET

Biotechnology

Company Overview of Ardelyx, Inc.

Company Overview

Ardelyx, Inc. discovers, develops, and commercializes minimally-systemic small molecule therapeutics for the gastrointestinal (GI) tract to treat cardio-renal, GI, and metabolic diseases. Its lead product candidate is tenapanor, a small molecule NHE3 inhibitor, which has completed Phase 2b clinical trial for the treatment of patients with constipation-predominant irritable bowel syndrome and hyperphosphatemic patients with chronic kidney disease on dialysis, as well as Phase 2a clinical trial in patients with late-stage chronic kidney disease. The company’s discovery and lead development programs that are in research phase include RDX002 NaP2b inhibitor for hyperphosphatemia; RDX009 TGR5 ago...

34175 Ardenwood Boulevard

Suite 100

Fremont, CA 94555

United States

Founded in 2007

34 Employees

Phone:

510-745-1700

Fax:

510-745-0493

Key Executives for Ardelyx, Inc.

Chief Executive Officer, President and Director
Age: 50
Total Annual Compensation: $466.0K
Chief Financial Officer
Age: 47
Total Annual Compensation: $318.9K
Senior Vice President of Drug Development
Age: 54
Total Annual Compensation: $277.5K
Chief Scientific Officer and Executive Vice President
Age: 46
Total Annual Compensation: $132.1K
Compensation as of Fiscal Year 2014.

Ardelyx, Inc. Key Developments

Ardelyx, Inc. - Special Call

To consider initiation of Phase 3 Clinical Program in IBS-C Patients

Ardelyx, Inc. Announces New Product Candidate for the Treatment of Hyperkalemia to Begin Clinical Development in Mid-2015

Ardelyx, Inc. announced a new program, RDX022, a non-absorbed polymer, for the treatment of hyperkalemia. RDX022 is a novel, non-absorbed polystyrene sulfonate polymer being developed by Ardelyx to treat elevated potassium, or hyperkalemia, a potentially dangerous problem common among patients with chronic kidney disease (CKD) and heart failure. RDX022 is designed with improved chemical and physical properties as well as formulation improvements that may allow for a more palatable dosage form. The Company will be pursuing a 505b(2) regulatory pathway in the United States for RDX022, allowing Ardelyx a faster path to approval by referencing the literature and the U.S. Food and Drug Administration's previous findings of safety and effectiveness of the referenced drug product. Ardelyx will supplement this approach with nonclinical and Phase 3 clinical data on RDX022 to provide information for inclusion in the product label. The Company plans to progress RDX022 into late stage clinical development over the next 12-18 months. Ardelyx will begin early stage clinical trials in mid-2015. Assuming the successful completion of those trials, the Company expects to commence a Phase 3 clinical program to evaluate RDX022 for treatment in hyperkalemia patients as early as the second half of 2016. Ardelyx is also continuing research on its RDX013 small molecule drug candidate for hyperkalemia. This agent, a potential potassium secretagogue, is intended to enhance potassium secretion or prevent potassium absorption with a much lower pill burden than potassium binders and may provide significant advantages as a stand-alone agent or used in combination with the potassium binders, including RDX022.

Ardelyx, Inc. Presents Positive Results from Its Phase 2b Clinical Trial

Ardelyx, Inc. presented Phase 2b clinical trial results that demonstrated statistically significant and clinically meaningful improvement in IBS-C symptoms for tenapanor-treated patients compared to patients receiving placebo. As previously reported, at the 50 mg dose of tenapanor, the study met its primary efficacy endpoint of an increase in the complete spontaneous bowel movement (CSBM) responder rate. Most secondary endpoints, including abdominal pain and other abdominal and IBS-C symptoms, demonstrated clinically meaningful improvements. Tenapanor was well-tolerated, and the safety results were consistent with those observed in previous tenapanor trials. The Phase 2b clinical trial was a randomized, double blind, placebo-controlled, multi-center study to evaluate the safety and efficacy of three dose levels of tenapanor in 356 subjects with IBS-C as defined by the Rome III criteria and who had active disease as determined during a two-week screening period. Subjects who qualified and who were randomized into the study received 5, 20, or 50 mg of tenapanor or placebo twice daily for 12 consecutive weeks. At the end of this treatment period, subjects were followed for an additional 4 weeks. The primary endpoint, overall CSBM responder rate, was achieved in 60.7% of patients receiving tenapanor 50 mg twice daily versus 33.7% receiving placebo (p < 0.001). A responder was defined as a patient who had an increase of greater than or equal to one CSBM from baseline during 6 out of 12 weeks. The results are reported on an intent-to-treat basis. The overall abdominal pain responder rate was achieved in 65.5% of patients receiving tenapanor 50 mg twice daily versus 48.3% receiving placebo (p = 0.026). An overall abdominal pain responder was defined as a patient who experienced at least a 30% decrease in abdominal pain from baseline for 6 of 12 weeks. The overall responder rate, or dual composite endpoint percent was achieved in 50.0% of patients receiving tenapanor 50 mg twice daily versus 23.6% receiving placebo (p < 0.001). An overall responder was defined as a patient who was both an overall CSBM responder and an overall abdominal pain responder in the same week for 6 of 12 weeks. A dose response relationship among all doses was observed in the primary endpoint, as well as in most secondary endpoints, although statistical significance was not achieved at the 5 mg or 20 mg doses. Additionally, the activity of tenapanor was maintained throughout the entire 12-week treatment period. Tenapanor was well-tolerated in these patients, and the safety results were consistent with those observed in previous tenapanor trials. The most common adverse events at 50 mg twice daily (greater than or equal to 5%) that occurred more frequently in tenapanor-treated patients compared to placebo-treated patients were diarrhea at 11.2% vs. 0%, and urinary tract infections at 5.6% vs. 4.4%. Overall rates of discontinuation due to adverse events were 4.5% (3.3% due to diarrhea) for the tenapanor-treated patients (50 mg twice daily) and 3.3% for the placebo-treated patients. Based on the analysis of plasma samples tested as part of the study, the minimally systemic nature of tenapanor was confirmed.

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