Ardelyx Launches 'Can We Do Better?' Campaign at ASN's Kidney Week 2020

Rhea-AI Summary

Ardelyx, Inc. (Nasdaq: ARDX) launched its 'Can We Do Better?' campaign at Kidney Week 2020, highlighting the challenges of hyperphosphatemia in chronic kidney disease patients on dialysis. The campaign emphasizes the limitations of current phosphate binders, which fail to maintain target phosphorus levels for 77% of patients over six months. Ardelyx aims to develop targeted therapies based on new insights into phosphate absorption mechanisms. The lead candidate, tenapanor, is under FDA review for controlling serum phosphorus levels.

Positive

• Launch of the 'Can We Do Better?' campaign to address hyperphosphatemia in kidney disease patients.
• Focus on developing novel therapies based on new insights into phosphate absorption.
• Lead candidate tenapanor currently under FDA review.

Negative

• Current phosphate binders inadequately control phosphorus levels for most patients (77% fail to maintain levels <5.5 mg/dL).
• Dependence on phosphate binders poses a challenge due to their complex administration.

FREMONT, Calif., Oct. 22, 2020 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company developing targeted, first-in-class medicines to improve the lives of patients with kidney and cardiovascular diseases, today announced the launch of its 'Can We Do Better?' Campaign at Kidney Week 2020, this year's virtual Annual Meeting of the American Society of Nephrology (ASN) that is now underway. With a new and deeper mechanistic understanding of phosphate absorption, Ardelyx is developing a new approach to advance patient care.

THE PROBLEM: Hyperphosphatemia has been shown to be an independent risk factor for high rates of cardiovascular morbidity and mortality in patients with chronic kidney disease (CKD) on dialysis. Unfortunately, most of these patients are unable to consistently achieve target phosphorus levels with the use of phosphate binders, the only currently available medications approved for the treatment of hyperphosphatemia:

• IN ANY GIVEN MONTH: ~42% of phosphate binder-treated patients on dialysis have phosphorus levels greater than the recommended target level of 5.5 mg/dL.*
• OVER A 6-MONTH PERIOD: ~77% of phosphate binder-treated patients on dialysis are unable to consistently maintain phosphorus levels <5.5 mg/dL.*

THE REASON FOR THE PROBLEM: There are limitations implicit to the mechanism of action of phosphate binders, the only class of medication approved for the treatment of hyperphosphatemia. Phosphate binders act by binding dietary phosphorus in the gut and because of how they work, must be taken with every meal, are large in size, and often require many pills per dose. These limitations make consistently achieving target phosphate levels extremely challenging for a large proportion of patients.

ADVANCING THE SCIENCE: It's time to look deeper into the science of phosphate absorption:

• NEW SCIENCE: Scientists at Ardelyx have discovered that dietary phosphate absorption occurs primarily through the paracellular pathway.
• THE OPPORTUNITY: With this new knowledge comes great opportunity - to develop novel mechanism, non-binder, targeted therapies that could provide a completely new approach to the treatment of hyperphosphatemia.

The full campaign can be viewed at https://www.advancingphosphatecontrol.com/.

About Ardelyx, Inc.
Ardelyx is a biopharmaceutical company translating scientific breakthroughs into promise for patients, driven to advance targeted therapies where significant medical needs persist. We have developed a unique and innovative platform that has enabled the discovery of new biological mechanisms and pathways to create targeted, first-in-class, oral, small molecule therapies to meet these needs. Our lead candidate, tenapanor, is currently under FDA review for the control of serum phosphorus in adult patients with chronic kidney disease on dialysis. Our discovery platform has also led us to the discovery of a lead candidate in our RDX013 program for the potential treatment of high potassium, or hyperkalemia, a common condition in patients with kidney and/or heart disease. For more information, please visit https://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 to be approved for marketing by the FDA for the control of serum phosphorus in chronic kidney disease patients on dialysis. Such forward-looking statements involve substantial risks and uncertainties that could cause the development of Ardelyx's product candidates 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 associated with the regulatory approval process, and uncertainties in the drug commercialization 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 6, 2020, and its future current and periodic reports to be filed with the Securities and Exchange Commission.

*Source: Spherix Global Insights: RealWorld Dynamix, Dialysis 2019

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SOURCE Ardelyx

FAQ

What is the 'Can We Do Better?' campaign by Ardelyx?

The 'Can We Do Better?' campaign aims to tackle the issues of hyperphosphatemia in chronic kidney disease patients, highlighting the limitations of current phosphate binders.

Why are phosphate binders ineffective for many dialysis patients?

Phosphate binders often fail because they must be taken with every meal, are large in size, and require multiple pills, leading to inconsistent phosphorus level control.

What is Ardelyx's lead candidate for treating hyperphosphatemia?

Ardelyx's lead candidate is tenapanor, which is currently under FDA review for controlling serum phosphorus levels in chronic kidney disease patients.

When did Ardelyx launch its campaign at Kidney Week 2020?

Ardelyx launched its 'Can We Do Better?' campaign on October 22, 2020, during Kidney Week 2020.

What percentage of dialysis patients struggle to maintain target phosphorus levels?

Approximately 77% of phosphate binder-treated dialysis patients are unable to maintain phosphorus levels below 5.5 mg/dL over a six-month period.